Sr. Process Development Engineer

Resonetics; Fridley (MN); On-site; USD 105,000 - 135,000; Full time

Job summary

Resonetics, a global leader in advanced engineering and micro manufacturing for the medical device industry, seeks a Senior NPI/Process Development Engineer in Minnesota. You’ll develop and validate manufacturing processes for Class 3 active implantable devices and support readiness for commercial production.

The role emphasizes cost, quality, continuous improvement, and strong customer service across cross-functional teams, reporting to the NPI leadership.

Qualifications

• Bachelor’s degree in engineering or related field.
• 5+ years related experience in medical device industry with a heavy focus on product or process development of Active Implantable Devices.
• Experience with process validations for laser welding, header attachment, and internal moisture bake and Test Method Validation for Helium Leak Testing.
• Demonstrated ability to independently develop medical device manufacturing processes from concept to production.
• Experience with medical device Design For Manufacturing, design control, quality systems and product development phases.
• Demonstrated ability to implement change that improves department and company performance.
• Ability to handle multiple projects simultaneously.
• Team player with strong interpersonal skills and cross-functional drive.
• Experience with SolidWorks and/or Mastercam.
• MS Office Proficiency.

Responsibilities

• Develop and validate processes used to manufacture components, sub-assemblies, and finished devices.
• Lead and mentor junior engineers and technicians.
• Act as liaison between development and operations.
• Ensure processes are repeatable and meet design requirements.
• Prepare and present detailed project plans and milestones.
• Coordinate resources, facilities, and equipment for projects.
• Improve production controls, SOPs, safety, quality, and training systems.
• Prepare layouts of buildings and equipment for manufacturing.
• Coordinate manufacturing launches for new or revised products.
• Design, develop, test, and source tools and equipment for manufacturing methods.
• Conduct product/process analysis for production and quality metrics.
• Write engineering change orders to update docs and BOMs.
• Support finance, HR, quality, regulatory, and clinical as needed to ensure compliance.
• Recommend and implement process improvements and new equipment.
• Lead capital expenditure justifications.
• Assist production transfers from R&D to manufacturing.

Skills

Project management

Cross-functional collaboration

Process development

Quality systems familiarity

MS Office

Education

Bachelor's degree in engineering

Tools

SolidWorks

Mastercam

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Senior NPI/Process Development Engineer is a key member of a team developing and bringing to market Class 3 active implantable devices. The role requires collaboration and partnership with Active Implantable Design Engineers and core teams and is responsible for developing and validating the manufacturing processes and approaches to support readiness for commercial production. In addition, the NPI engineer also focuses on costs, quality, continuous improvement, and high level of customer service.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices.
• Provides leadership and mentors less experienced engineers and technicians.
• Acts as the liaison between development and operations.
• Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements.
• Prepares and presents detailed plans necessary to complete assigned projects.
• Develops schedule milestones, coordinates resources, facility and equipment for assigned projects.
• Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
• Prepares and maintains detailed layouts of buildings and equipment.
• Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
• Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
• Performs product/process analysis for production and quality metrics.
• Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials.
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.
• Recommend, support and implement improvements, modifications, or additions that will improve work processes.
• Take the lead in analyzing the need for new process development and to meet company needs including specifying, ordering, installing and validating new equipment or processes.
• Prepares justification for capital expenditures.
• Aid in production transfers from R&D to manufacturing.
• Performs other related duties as assigned by management.

Required Qualifications

• Bachelor’s degree in engineering or related field
• 5+ years related experience in medical device industry with a heavy focus on product or process development of Active Implantable Devices. Strongly preferred experience in Neuromodulation Devices (IPGs or Leads). Experience with pacemakers, cardiac monitors, brain computer interface, etc. also considered
• Extensive experience with process validations for laser welding, header attachment, and internal moisture (bake) and Test Method Validation for Helium Leak Testing
• Demonstrated ability to independently develop medical device manufacturing processes from concept to production
• Experience with medical device Design For Manufacturing, design control, quality systems and product development phases
• Demonstrated ability to implement change in a way that positively impacts overall department and company performance
• Must be able to handle multiple projects simultaneously
• Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
• Experience using influence to affect project and organizational success
• Experience with programs including SolidWorks and/or Mastercam
• MS Office Proficiency
• Ability to handle and be trusted with confidential and/or sensitive information

Physical Demands

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at times.
• Must have excellent hand-eye coordination.
• Ability to differentiate between colored wires, tabs, and electronic components.
• Must wear gown, gloves, and ear protection if applicable.

Compensation

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $105,000–$135,000.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.