Principal Process Development Engineer

Posted 6 Days Ago
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Fridley, MN, USA
In-Office
118K-186K Annually
Expert/Leader
Hardware • Healthtech • Manufacturing
The Role
Leads the development, optimization, validation, and implementation of medical device manufacturing processes. Responsibilities include coordinating projects, equipment and facility planning, manufacturing launches, process and quality analysis, engineering change orders, production transfers, capital expenditure justification, automation initiatives, and lean manufacturing improvements. Provides technical leadership and coaching while collaborating cross-functionally with operations, quality, regulatory, finance, and clinical teams.
Summary Generated by Built In
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 Principal Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective and compliant manufacturing processes and methods in accordance with product specifications and quality standards.

Responsibilities
  • Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices
  • Provides leadership and coaches less experienced engineers and technicians.
  • Acts as the liaison between development and operations
  • Coaches less experienced engineers and technicians
  • 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
  • Prepare justification for capital expenditures
  • Aid in production transfers from R&D to manufacturing
  • Propose potential new manufacturing technologies, including automation and new equipment
  • Contribute to the definition, development and implementation of LEAN manufacturing initiatives
Required Qualifications
  • Bachelor’s degree in engineering or related field  
  • 10+ years related experience in medical device industry with a focus in Process Development
  • 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 $118,000K-$186,000.
  • 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.

Skills Required

  • Bachelor's degree in engineering or a related field
  • 10+ years of related experience in the medical device industry, focused on process development
  • Ability to independently develop medical device manufacturing processes from concept through production
  • Experience with medical device Design for Manufacturing, design controls, quality systems, and product development phases
  • Ability to implement changes that positively impact department and company performance
  • Ability to handle multiple projects simultaneously
  • Strong teamwork, interpersonal, and cross-functional leadership skills
  • Experience using influence to drive project and organizational success
  • Experience with SolidWorks and/or Mastercam
  • Proficiency with Microsoft Office
  • Ability to handle confidential and sensitive information
  • Must already be legally authorized to work in the United States without current or future sponsorship

Resonetics Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Resonetics and has not been reviewed or approved by Resonetics.

  • Healthcare Strength — Healthcare coverage is described as solid, with broad coverage and in some cases day-one eligibility. Medical coverage is viewed as a dependable pillar of the total rewards package.
  • Leave & Time Off Breadth — Paid time off is commonly provided and taking time away is often described as straightforward, though administration can vary by site. This breadth offers a practical counterweight to concerns about base pay for some roles.
  • Retirement Support — Retirement benefits, including 401(k) features with immediate vesting in some cases, are highlighted as part of a comprehensive package. These elements strengthen long-term financial security beyond base wages.

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The Company
HQ: Nashua, NH
2,600 Employees
Year Founded: 1987

What We Do

Resonetics is a medical device contract development and manufacturing organization serving MedTech partners. Founded in Nashua, New Hampshire, it provides advanced engineering, prototyping, product development, micromanufacturing, sensor technologies, and value-added manufacturing. Its integrated services support medical-device innovation from ideation through commercialization, helping customers develop precise, scalable solutions and accelerate time to market. Its processes are designed for the precision and reliability required by life-critical medical devices.

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