Education Required

• Bachelor's Degree in engineering/technology
• Electrical Engineering degree preferredExperience Required
• 5-10 years of experience in a design and/or development setting at a medical device company
• Experience with Medical Device design controls
• Previous operational experience supporting New Product Development (preferred)
• Product development experience in the medical device industrySkills Required
• Proficient in Medical Device design controls; able to provide guidance to team members
• Working understanding of design controls, including

FDA 21 CFR

820.30 and

ISO 9001

sub-clause 4.4

• Working understanding of

IEC 60601-1

(medical electrical equipment - general safety and essential performance)

• Experience with development and verification of electronic medical equipment with embedded firmware
• Solid technical understanding of engineering principles and procedures
• Ability to prioritize multiple tasks
• Ability to use engineering tools to solve straightforward problems (e.g., Design of Experiments, SPC)
• Ability to study and recommend techniques to improve existing products
• Ability to help determine verification testing and other product tests to assure product design
• Effectively operate in and may facilitate cross-functional teams with guidance
• Ability to provide solutions that reflect understanding of business objectives and cost implications
• Strong communication skills
• Ability to work well as a leader/member of cross-functional teamsJob Description
• Serve as the technical lead in product development activities for electronic end-of-life activities
• Develop solutions to routine technical problems associated with current product design
• Coordinate with suppliers and external resources needed to develop and implement updates to existing designs to maintain existing function
• Liaise with exterior contractors and Operations teams to develop additional capability for existing technology and product improvements
• Function within a team environment and provide clear feedback to supervisor and department
• Work with multi-functional team to deliver Voice of Business and Project requirements
• Proficient in Medical Device design controls and provide guidance to team members
• Prioritize multiple tasks
• Utilize engineering tools to solve straightforward problems (e.g., Design of Experiments, SPC, etc.)
• Study and recommend techniques to improve existing products
• Help determine verification testing and other product tests to assure product designWork Arrangement
• Hybrid
• Monday-Friday, 3 days onsite, 2 remote
• First 1-2 weeks must be onsitePhysical / Environmental Requirements
• Repetitive work with a personal computer
• Periodic lifting of up to 35 pounds
• Time divided between desk work in a standard office environment and standing/moving in production, laboratory, and warehouse areas
• A variety of chemicals are used in production and laboratory areas routinely
• May be required to observe surgical procedures while in an operating theater