The Product Development Engineer is part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices. The individual reports to the Director of Product Development.

RESPONSIBILITIES:

• Summary and refinement of product specifications
• Brainstorming of innovative device design concepts
• CAD design of device concepts
• Prototyping and evaluation of design concepts
• Engineering design analysis, including tolerance analysis
• Development and maintenance of drawing packages
• In-vitro test method development and fixture design/fabrication
• In-vivo and in-vitro study protocol development, execution, reporting
• Development of manufacturing processes and documentation
• Creation and maintenance of design controls documentation
• Generation of product risk analyses
• Initiation of document change orders, purchase orders or other business processes in support of product development activities
• Fostering of client relationships and provision of responsive service in a contract environment
• Adherence to Quality Management System procedures/design controls

REQUIRED QUALIFICATIONS:

See Preferred Qualifications.

PREFERRED QUALIFICATIONS:

• Preferred Education: B.S. in Mechanical or Biomedical Engineering
• Preferred Experience:0 to 4 years’ experience in product development in an engineering or manufacturing role

Proficiency with MS Office suite and SolidWorks
Familiarity with ISO 13485 and 21 CFR is preferred
Familiarity with design for manufacturability is preferred
Detail-oriented and comfortable working in a highly regulated environment
Excellent analytical skills and the ability to solve complex design issues
Strong communication and teamwork skills

• MBA or Project Management degree
• Lean, six-sigma green or black belt certified

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Product Development: 1 year (Required)
• MS Office suite and SolidWorks: 1 year (Required)

License/Certification:

• Lean, six-sigma green or black belt certified (Preferred)

Work Location: One location

• Health insurance