Process Development Engineer – Medical Devices
Location: On-site (local travel only, no overnight)
Travel: Up to 10% (local only)
Visa Sponsorship: Not available
Pay rate up to $56/hr
Position Overview
We are seeking a motivated, collaborative, and creative individual to join a high-performing Process Development team focused on next-generation technologies and products for advanced cardiac devices. This role offers strong opportunities for growth and will involve driving innovative technology solutions from concept to commercialization. You will partner cross-functionally with a technically strong, experienced, and highly engaged team.
Key Responsibilities
- Own equipment, processes, inspections, development builds, and drive improvements in associated technology and methodology.
- Position future projects for success by reducing Human Visual Inspection (HVI) in manufacturing.
- Manage processes and key deliverables through DV, PV, and commercial launch.
- Collaborate with R&D, Equipment Engineering, Manufacturing Engineering, and Design Assurance to develop product concepts, equipment, inspections, and influence design specifications.
- Provide Design for Manufacturability (DFM) input to engineering print packages.
- Develop new assembly and inspection capabilities for complex equipment.
- Train, mentor, and provide work direction to engineers and technicians; train manufacturing personnel as needed during validations.
- Communicate technical data and recommendations clearly and concisely.
- Solve complex technical problems in a hands-on manner within a fast-paced, dynamic environment.
- Develop, write, and review process validation strategies and related deliverables (e.g., experiment reports, GR&R, TMV, IQ, FMEA).
- Serve as a core team member, workstream lead, or extended team member on new product development projects.
Quality Systems Duties
- Build quality into all aspects of work by maintaining compliance with applicable quality requirements.
Required Qualifications
- Bachelor’s degree in engineering or relevant technical field.
- Minimum of 4 years of professional experience in a related role.
- Prior experience in medical device or other regulated industry.
- Demonstrated cross-functional collaboration and influence in technical environments.
- Experience with automated inspection and/or assembly equipment.
- Strong problem-solving and root cause investigation skills.
- Expertise in new product development and/or operations.
- Experience with process verification and validation (TMVs, OQ/PQs).
- Proficiency in statistical methods to drive improvements.
- Strong written and verbal communication, decision-making, and critical thinking skills.
Preferred Qualifications
- Experience with Nitinol manufacturing.
Additional Notes
- This position requires on-site work.
- Possible temp-to-hire opportunity for the right candidate, depending on budget.
