Job Title: Principal Catheter Engineer
Reports to (title): Director of Engineering, Disposables

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
? Lead the design, development, and specification creation for single-use intravascular
imaging catheters, components, and related manufacturing methods.
? Lead activities such as program management, usability studies, design reviews,
feasibility analysis, technical development, performance testing, and pilot manufacturing process validation.
? Create and review design verification test protocols and reports, design of experiments, and risk management file deliverables such as hazard analyses, FMEAs, etc.
? Work and collaborate cross-functionally with internal and external teams to drive
catheter product development, obtain necessary resources, and ensure company
objectives are met.
? Lead and mentor other members of the catheter engineering team, providing daily
direction as needed during assigned project work.
? Ensure adherence to established design control processes, good engineering practices, and the company quality policy. Other duties as assigned.

EXPERIENCE/EDUCATION/SKILL REQUIREMENTS:
Minimum of 9-12 years of technical design and medical product development experience with a four-year technical degree or 5-8 years with an advanced degree. A working knowledge in the following areas:
? Medical device development with sterile single-use disposables
? Specification development
? Medical device design controls or equivalent via work in highly regulated industries
? Sterilization processes
? CAD design
? Statistical analysis including capability and tolerance analyses
? Catheter manufacturing processes including injection molding, extrusions, RF and
ultrasonic welding, adhesives, etc.
? Metrology
? Risk management processes including d/pFMEA, specification traceability, hazards
analysis and statistical treatment of risks
? Leadership/mentorship
? Verification testing
? Analytic approach to design development including first principles analyses, finite
element simulations, statistical modeling, etc.

Job Type: Full-time

Pay: Up to $190,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Sudbury, MA 01776: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• medical device industry: 9 years (Preferred)
• product design and development: 9 years (Preferred)
• intravascular catheter design/development: 9 years (Preferred)
• CAD: 10 years (Preferred)

Work Location: Hybrid remote in Sudbury, MA 01776

• Health insurance