JCW Group · 1 week ago
Principal Process Development Engineer
Twin Cities Area
Full-time
Onsite
Lead/Staff
$125K/yr - $165K/yr
8+ years expJCW Group is seeking a Principal Process Development Engineer to lead the development and validation of manufacturing processes for catheter-based medical devices. This senior, hands-on technical leadership role involves transforming early R&D concepts into robust, validated, manufacturing-ready processes while collaborating with R&D, Manufacturing, and Quality teams.
Human ResourcesRecruitingStaffing Agency
Hiring Manager
Maddie Lavery
Responsibilities
Lead process development activities from early R&D through pilot line build, validation, and manufacturing transfer
Serve as technical lead for process development across one or more catheter programs
Translate design requirements into capable, repeatable manufacturing processes
Design and specify production equipment, tooling, fixtures, and work instructions
Develop and execute process characterization studies and yield improvement initiatives
Own PFMEAs, control strategies, and validation plans (IQ/OQ/PQ)
Lead execution of OQ/PQ and support regulatory submissions as needed
Train operators and support pilot line operations through stabilization
Partner closely with R&D to ensure design-for-manufacturability and smooth transfer
Identify process risks early and implement effective mitigation strategies
Mentor engineers and technicians and provide technical leadership across teams
Qualification
Required
Bachelor's degree in Engineering
8+ years of medical device process development experience, with strong catheter background
Proven experience building processes from concept into validated manufacturing lines
Deep understanding of design controls, process validation, and quality systems
Strong data-driven problem-solving and statistical analysis skills
Ability to operate independently and lead complex initiatives with minimal direction
Preferred
Electromechanical or automated process exposure
Background in small-to-mid-sized OEMs or CMOs
Experience supporting scale-up and manufacturing transfer
Company
JCW Group
JCW Group is a recruitment company that offers talent solutions to businesses.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jamie Woods
Founder / Chairman
Company data provided by crunchbase