Process Development Engineer

Process Development Engineer - Maple Grove, MN

Join our team as a Process Development Engineer! This role offers the chance to work on next-generation WATCHMAN devices, driving technology solutions from concept to commercialization. Collaborate with cross-functional teams in R&D, Equipment Engineering, Manufacturing, and Design Assurance to develop equipment, inspections, and processes that improve quality and efficiency.

Schedule: Monday-Friday, 8:00 AM - 4:30 PM

Pay: $56 per hour

Key Responsibilities

• Lead development and improvement of equipment, processes, inspections, and development builds
• Drive Human Visual Inspection (HVI) reduction and process improvements for WATCHMAN manufacturing
• Manage processes and key deliverables through Design Verification (DV), Process Verification (PV), and commercial launch
• Collaborate with R&D, Equipment Engineering, Manufacturing, and Design Assurance to influence design specifications and provide Design for Manufacturability (DFM) input
• Develop new assembly and inspection capabilities for complex equipment
• Train, mentor, and guide engineers, technicians, and manufacturing personnel as needed
• Analyze technical data and communicate recommendations clearly
• Solve complex technical problems in a fast-paced, hands-on environment
• Develop, write, and review process validation strategies and deliverables (Experiment Tech Reports, GR&R, TMV, IQ, FMEA, OQ/PQ)
• Serve as a core team member, workstream lead, or extended team member on new product development projects

Quality Responsibilities

• Maintain compliance with all quality system requirements and build quality into all work

Required Qualifications

• Bachelor's degree in Engineering or related technical field
• 4+ years of experience in medical device or regulated industry
• Experience with Automated Inspection and/or Assembly Equipment
• Strong cross-functional collaboration and influence in technical environments
• Expertise in New Product Development, Process Verification, and Validation (TMV, OQ/PQ)
• Skilled in problem solving, root cause analysis, and applying statistics to drive improvements
• Strong written and verbal communication, decision-making, and critical thinking skills
• Ability to travel locally up to 10%

Preferred Qualifications

• Experience with Nitinol manufacturing

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

Apply Now to be part of a team that drives life-changing technology from concept to commercialization!

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Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.