Director of Quality

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop, and deliver products. Our clients encompass a broad variety of markets and technologies, and we value employees who are versatile and able to quickly adapt to new challenges.

We are currently searching for a Director of Quality with extensive experience in product development and manufacturing of medical devices to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, thorough experience working within ISO 13485 and 21 CFR Part 820 -compliant quality systems, knowledge of other applicable regulations, and a knowledge of the product development cycle. Excellent communication and interpersonal skills and a passion for product development are essential to our team.

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

• Managing and growing a team of Quality Engineers
• Administering a Quality Management System compliant to ISO 13485 and other regulatory standards
• Hosting and managing ISO, FDA and customer inspections/audits of the facilities and Blur QMS
• Overseeing the medical device design control documentation and processes on simultaneous projects, including writing verification protocols, project plans, and hosting design reviews
• Cooperative work with the Blur Director of Operations and Manufacturing Engineers on project priorities and solutions to customer needs
• Training of R&D, Operations and Quality team members on QMS practices
• Coordinating and executing internal and supplier audits
• Completion of quality inspection and testing as needed
• Assembly procedure and specification development and review for details and process clarity
• Working with other personnel to continuously improve the quality system, leveraging previous quality experience
• Maintenance of records and document control
• Reviewing documentation to ensure compliance, including DHR and Change Request
• Creation, ownership and approval of CAPA and NCMR documentation when failures are found

Skills/Qualifications:

• BS, preferably in an engineering discipline
• 8-10 years of experience in Quality with respect to medical devices or a similar field
• Experience in technical testing and documentation of test results and failures
• Detailed understanding of measurement tools and systems
• Statistical methods, including determination of inspection and V&V sample sizes, trending analyses, establishing confidence intervals, and calculation of process parameters
• Knowledge of GD&T
• Hands-on experience with electro-mechanical assemblies
• Knowledge of ISO 13485, FDA 21 CFR, and other, similar applicable regulations
• Excellent organizational and project management skills
• Experience in writing quality SOPs and conducting audits
• Creative problem-solving and detail oriented

Director of Mechanical Engineering

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop and deliver products. Our clients encompass a broad variety of markets and technologies, and we value employees who are versatile and able to quickly adapt to new challenges.

We are currently searching for a Director of Mechanical Engineering with extensive experience in product development to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, mastery of engineering principles, and practical knowledge of manufacturing processes. Excellent communication and leadership skills, and a passion for product development are essential to our team.

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

• Lead the mechanical design team, including project planning and mentorship
• Interface with clients
• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Participate in concept brainstorming meetings
• Perform mechanical design for new medical and consumer products
• Follow medical device design controls, including design documentation and writing and executing verification test protocols
• Assist vendors in design transfer and troubleshooting manufacturing processes

Skills/Qualifications:

• BS, Mechanical Engineering or equivalent, advanced degree a plus
• 10+ years of mechanical engineering experience in product development
• Experience leading projects and teams
• Proficient in SolidWorks
• Experience with Finite Element Analysis
• Understanding of a wide array of manufacturing methods
• Medical device experience is a plus
• Excellent verbal and written communication skills

Senior Mechanical Engineer

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop and deliver products. Our clients encompass a broad variety of markets and technologies, and we value employees who are versatile and able to quickly adapt to new challenges.

We are currently searching for a Senior Mechanical Engineer with extensive experience in product development to join our office in Cary. The ideal candidate will demonstrate a history of creative problem-solving, mastery of engineering principles, and practical knowledge of manufacturing processes. Excellent communication and interpersonal skills, and a passion for product development are essential to our team.

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Participate in concept brainstorming meetings
• Perform mechanical design for new medical and consumer products
• Build prototypes, perform testing, and iterate
• Produce detailed component and assembly drawings
• Supply chain management, including part fabrication, component selection, and assembly
• Follow medical device design controls, including design documentation and writing and executing verification test protocols
• Assist vendors in design transfer and troubleshooting manufacturing processes
• Interface with clients
• Provide mentorship to other team members

Skills/Qualifications:

• BS, Mechanical Engineering, Biomedical Engineering or equivalent, advanced degree a plus
• Background in disciplines in addition to ME will be valued
• 7+ years of mechanical engineering experience in product development
• Proficient in SolidWorks
• Experience with Finite Element Analysis
• Understanding of a wide array of manufacturing methods
• Medical device experience is a plus
• Excellent verbal and written communication skills

Technical Project Director

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop and deliver products. Our clients encompass a broad variety of markets and technologies, and we value team members who are versatile and able to quickly adapt to new challenges.

We are currently searching for a Technical Project Director with experience in product development to join our office in Cary, NC. The ideal candidate will demonstrate a history of successfully managing projects, creative problem solving, interfacing with stakeholders, and technology and systems engineering acumen. Excellent communication and interpersonal skills, and a passion for product development are essential to our team.

Job Type:

• Full-Time Employee

Key Responsibilities:

• Lead, coordinate, and drive project planning and project management
• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Develop and monitor project plans with timelines/milestones
• Participate in concept brainstorming meetings
• Responsible for building and maintaining positive client relationships
• Author design controls documentation for medical devices
• Lead regular update meetings for both staff and senior management to ensure project status is well understood

Skills/Qualifications:

• BS, preferably in an engineering discipline
• 5+ years of project/team management experience
• 5+ years systems engineering experience
• Highly proficient in Jira, Confluence, MS Project, Smartsheet, or similar project management tools
• Familiarity with quality systems, preferably under ISO 13485
• Fluent in engineering of electromechanical systems, particularly medical devices
• Familiarity with a variety of manufacturing processes
• Excellent verbal and written communication skills

IT Technician

Description:

We are currently searching for an IT Technician with experience providing support for a growing organization in a fast-paced environment, including managing employee PCs and maintaining computer systems and networks, to join our Cary office. The ideal candidate will demonstrate a thorough knowledge of computer software and hardware and a variety of internet applications, networks, and operating systems. They will also possess exceptional troubleshooting abilities and attention to detail. Excellent communication and interpersonal skills are also essential to our team.

Job Type:

• Permanent Part-Time Employee

Key Responsibilities:

• Set up PCs for new employees (Microsoft Office, Dropbox, etc.)
• Sanitize PCs for departing employees (Reset PC to defaults, remove old data, etc.)
• Provide IT support for employee computer issues (troubleshoot computer issues, email issues, etc.)
• Provide IT support for infrastructure (WiFi maintenance, etc.)
• Provide maintenance of on-site storage (Managing user accounts)
• Provide maintenance of cloud-based systems (Fishbowl

Skills/Qualifications:

• AS or BS in Computer Science, Information Systems or related field, or equivalent experience, advanced degree or certification a plus
• Up-to-date knowledge of new systems, information, software, and upgrades
• Ability to troubleshoot and resolve multiple issues
• Ability to multitask, prioritize, and manage time efficiently
• Excellent verbal and written communication skills

Supply Chain Buyer

Description:

We are currently searching for a Buyer/Supply Chain Analyst with experience in buying components and goods to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, supplier onboarding and practical knowledge of manufacturing processes. Excellent communication and interpersonal skills, and a passion for product development are essential to our team. 

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

•  Will be procuring components 

• Finding part replacements for obsolete or long lead items 

• Tracking inventory cost by customers

• Negotiating terms with suppliers 

• Forecasting and ordering 

• Maintaining Inventory 

• Follow medical device requirements for FDA and ISO 13485 

Skills/Qualifications:

•  Previous experience in supply chain or in a similar field 

• Excellent knowledge of supply chain processes 

• Working experience of relevant software (e.g. MRP) 

• Strong communication skills 

• Excellent organizational and project management skills 

• Attention to detail 

• Creative problem-solving 

• A strategic and analytical mind 

• Degree in Supply Chain Management, Logistics, or similar 

Project Manager

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop and deliver products. Our clients encompass a broad variety of markets and technologies, and we value team members who are versatile and able to quickly adapt to new challenges. We are currently searching for a Project Manager with experience in product development to join our office in Cary, NC. The ideal candidate will demonstrate a history of successfully managing projects, creative problem solving, and technology and engineering acumen. Excellent communication and interpersonal skills, and a passion for product development are essential to our team.

Job Type:

• Full-Time Employee

Key Responsibilities:

• Lead, coordinate, and drive project planning and project management
• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Develop and monitor project plans with timelines/milestones
• Participate in concept brainstorming meetings
• Responsible for building and maintaining positive client relationships
• Author design controls documentation for medical devices
• Lead regular update meetings for both staff and senior management to ensure project status is well understood

Skills/Qualifications:

• BS, preferably in an engineering discipline; PMP certificate a plus
• 5+ years of project management experience
• Highly proficient in MS Project, Smartsheet, or similar project management tools
• Familiarity with quality systems, preferably under ISO 13485
• Positive attitude and ability to interact with all levels of Blur team to coordinate and execute R&D activities
• Fluent in engineering of electromechanical systems, particularly medical devices
• Familiarity with a variety of manufacturing processes
• Excellent verbal and written communication skills

Manufacturing Engineer

Description:

Blur is a medical device product development and manufacturing consulting firm serving the healthcare markets. We hire talented individuals with a passion for delivering results. Our clients encompass a broad variety of markets and technologies, and we value employees who are versatile and able to quickly adapt to new challenges. We are currently searching for a Manufacturing Engineer to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, mastery of engineering principles, and practical knowledge of manufacturing processes. Excellent communication and interpersonal skills, and a passion for product development are essential to our team.

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Perform assembly and test fixture design for new medical and consumer products
• Produce detailed component and assembly drawings
• Generate assembly instructions
• Supply chain management, including part fabrication, component selection, and assembly
• Follow medical device design controls, including design documentation and writing and executing verification test protocols
• Assist vendors in design transfer and troubleshooting manufacturing processes

Skills/Qualifications:

• BS, Mechanical or Electrical Engineering or equivalent
• 5+ years of manufacturing engineering experience in product development
• Proficient in SolidWorks and/or PTC Creo
• Experience managing projects and teams, able to manage client interface
• Understanding of a wide array of manufacturing methods
• Experience working within a quality system, preferable one that is ISO 13485 compliant
• Excellent verbal and written communication skills

Software Engineer

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop and deliver products. Our clients encompass a broad variety of markets and technologies, and we value employees who are versatile and able to quickly adapt to new challenges. We are currently searching for a Software Engineer with experience in product development to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, mastery of engineering principles, and practical knowledge of manufacturing processes. Excellent communication and interpersonal skills, and a passion for product development are essential to our team.

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Participate in concept brainstorming meetings
• Follow medical device design controls, including design documentation and writing and executing verification test protocols
• Develop software to client specifications and relevant standards
• Document software pursuant to medical device standards such as IEC 62304
• Help craft system architecture with mechanical and electrical engineering team

Skills/Qualifications:

• BS, Computer Science or equivalent, advanced degree a plus
• Versatility will be highly valued, particularly mechanical and electrical aptitude and medical device experience
• 3-10 years of software engineering experience
• Experience in PC software development in C/C++
• Experience with developing UIs (preferably using QT)
• Background in user experience, GUI design, and implementation
• Excellent verbal and written communication skills

Electrical Engineer

Description:

Blur is an innovation and product development consulting firm serving the healthcare, consumer, and industrial markets. We hire talented individuals with a passion for delivering results who know how to design, develop and deliver products. Our clients encompass a broad variety of markets and technologies, and we value employees who are versatile and able to quickly adapt to new challenges. We are currently searching for an Electrical Engineer with experience in product development to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, mastery of engineering principles, and practical knowledge of PCBA manufacturing processes. Excellent communication and interpersonal skills, and a passion for product development, are essential to our team.

Job Type:

• Permanent Full-Time Employee

Key Responsibilities:

• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Participate in concept brainstorming meetings
• Lead architect for circuit development and analysis, including schematics and simulation, component specification, BOM development, and sourcing
• Coordinate firmware development for ARM Cortex based microcontrollers with internal software development team members, including leading communications with software contractors
• Create documentation packages and direct production runs, including PCB fabrication, component supply chain management, and board population
• Test and troubleshoot new and existing electrical designs
• Follow medical device design controls, including design documentation and writing and executing verification test protocols
• Manage and guide third-party standards testing, such as IEC 60601

Skills/Qualifications:

• BS, Electrical Engineering or equivalent, advanced degree a plus
• Versatility will be highly valued, particularly mechanical aptitude and medical device experience
• +7 years of electrical engineering experience with embedded products, analog circuits, HDI designs, signal integrity for high-speed digital designs (sub nanosecond rise and fall times), and circuit designs for rechargeable battery powered devices
• Experience specifically designing analog circuits utilizing operational amplifiers, transistors, and transformers to create, as an example: low voltage (less than 100V) constant current sources or signal conditioning circuits
• Understanding of firmware development in C/C++ for microcontrollers
• Experience in schematic design, board layout, and troubleshooting electrical circuits
• Proficient in Altium Designer or similar design software
• Experience managing projects and teams, able to manage client interface
• Understanding of current manufacturing methods
• Excellent verbal and written communication skills

Mechanical Engineer

Description:

We are currently searching for a Mechanical Engineer with experience in product development to join our office in Cary. The ideal candidate will demonstrate a history of creative problem solving, mastery of engineering principles, and practical knowledge of manufacturing processes. Excellent communication and interpersonal skills, and a passion for product development are essential to our team.

Job Type:

• • Permanent Full-Time Employee

Key Responsibilities:

• Will be involved in projects at all stages, from crafting proposals through design and manufacturing
• Participate in concept brainstorming meetings
• Perform mechanical design for new medical and consumer products
• Produce detailed component and assembly drawings
• Supply chain management, including part fabrication, component selection, and assembly
• Follow medical device design controls, including design documentation and writing and executing verification test protocols
• Assist vendors in design transfer and troubleshooting manufacturing processes

Skills/Qualifications:

• BS, Mechanical Engineering or equivalent, advanced degree a plus
• Background in disciplines in addition to ME will be valued
• 3-10 years of mechanical engineering experience in product development
• Proficient in SolidWorks and/or PTC Creo
• Experience with Finite Element Analysis
• Experience managing projects and teams, able to manage client interface
• Understanding of a wide array of manufacturing methods
• Medical device experience is a plus
• Excellent verbal and written communication skills