Principal Process Development Engineer

TT Electronics; Minneapolis (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

Join a leading manufacturer as a Principal Process Development Engineer, focusing on electromagnetic assemblies for medical products. This role involves leading process development, collaborating with cross-functional teams, and ensuring compliance with regulatory standards. Ideal candidates have over 10 years of experience and possess strong skills in mechanical and electrical engineering principles.

Qualifications

• Minimum 10+ years of experience in process development in medical device industry.
• Hands-on experience with validation (IQ/OQ/PQ) and root cause analysis.
• Strong understanding of medical device regulations and process validation requirements.

Responsibilities

• Lead development and validation of manufacturing processes for electromagnetic components.
• Collaborate with R&D, Quality, and Manufacturing teams.
• Generate and maintain technical documentation, including SOPs and validation reports.

Skills

Coil winding

Magnetic assembly

Motor integration

Soldering

Precision alignment

Project management

Cross-functional collaboration

Lean principles

Six Sigma principles

Statistical process control

Communication

Microsoft Office Suite

Education

Bachelor’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering

Master’s or PhD preferred

Tools

SolidWorks

Minitab

JMP

Job description

Company Overview

COME JOIN OUR JOURNEY!

When you join TT, you join our global community of visionaries, creators, and achievers dedicated to engineering and manufacturing electronic solutions enabling a safer, healthier and more sustainable world. Simply put, we are a global manufacturer with a passion for engineering advanced electronics that benefit our planet and people for future generations. We are committed to having a positive impact on the world through a culture built around safety, transparency, collaboration, and positive relationships. Our teams are fueled by performance and expertise, leading the charge in innovation, efficiency and delivering world-class customer service. Be part of the journey.

Role Overview and Responsibilities

The Principal Process Development Engineer will lead the development, optimization, and validation of manufacturing processes for electromagnetic assemblies used in medical products, including sensors, motors, coils, and electromagnetic subsystems. In addition to developing scalable and compliant production methods, this role includes mechanical engineering responsibilities related to product design, device integration, tooling, and system performance. The engineer will collaborate closely with R&D, Quality, and Manufacturing to drive innovation, reliability, and efficiency in product realization.

• Lead development and validation of manufacturing processes for electromagnetic components such as coils, solenoids, actuators, and integrated assemblies in medical products.
• Develop robust, scalable, and cost-effective processes including coil winding, soldering, potting, encapsulation, EMI shielding, and thermal bonding in medical products.
• Design process fixtures, tools, and jigs to support precise assembly and alignment of electromagnetic components.
• Implement automated and semi-automated solutions for high-complexity assemblies.
• Lead equipment selection, installation, and qualification (IQ/OQ/PQ).
• Conduct process feasibility studies, risk assessments (PFMEA), and design of experiments (DOE).
• Collaborate with R&D, Quality, and Manufacturing teams to ensure manufacturability and regulatory compliance.
• Identify and implement cost-reduction and process optimization opportunities.
• Interface with suppliers and contract manufacturers on process capabilities and technology transfers.
• Support design and testing of mechanical components and subassemblies used in electromagnetic medical devices.
• Apply mechanical design principles, including DFM/DFA, GD&T, stress/thermal analysis, and materials selection.
• Participate in failure analysis and root cause investigations for process- and design-related issues.
• Serve as the technical lead in cross-functional teams through concept development, design transfer, and production phases.
• Generate and maintain technical documentation including work instructions, SOPs, PFMEAs, process flow diagrams, and validation reports.
• Mentor junior engineers and act as a subject matter expert in electromagnetic and mechanical process development.
• Partners with the Sales team and outside customers for specific designs and new business opportunities.
• Assists in building product prototypes and production process debugging.
• This position requires approximately 20% sales-oriented travel and a consistent on-site presence.
• Other duties as required and/or assigned.

Qualifications, Skills and Attributes

• Bachelor’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering (Master’s or PhD preferred).
• Minimum 10+ years of experience in process development for electromechanical or electromagnetic systems, preferably in the medical device industry.
• Proven experience with coil winding, magnetic assembly, motor integration, soldering, and precision alignment.
• Strong understanding of medical device regulations (FDA QSR, ISO 13485) and process validation requirements (IQ/OQ/PQ).
• Hands-on experience with validation (IQ/OQ/PQ), root cause analysis, and statistical process control.
• Proficiency in CAD software (SolidWorks preferred), and statistical tools (Minitab, JMP).
• Experience writing and executing process validations and transfer documentation.
• This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e., “Green Card Holder”), Political Asylee, or Refugee.
• Proficient with Lean and Six Sigma principles to ensure that manufacturing requirements for efficient processes and practices are addressed on a timely basis.
• Excellent project management, communication, and cross-functional collaboration skills.
• Strong documentation skills and attention to detail is required. Good verbal skills to communicate technical issues with a varied audience is required.
• Commitment to work with a hands-on approach in a team atmosphere is required.
• Understand and communicate both business and engineering perspectives.
• Juggle multiple competing priorities.
• Embrace challenges and team collaboration for success.
• Influence various internal and external stakeholders to meet goals.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office Suite required.

Solving Technology Challenges for a Sustainable World

We want the very best people in our TT family across the globe – so we welcome applications from everyone, to celebrate a diverse mix of experiences, backgrounds and identities. We are committed to equality of opportunity for all and you can rest assured that TT Electronics takes positive steps to ensure we are an inclusive business, that will welcome and support you, from your initial application to wherever your career takes you! Please get in touch if you’d like to discuss any reasonable adjustments to your application, in order that we can accommodate and support you in the process. If you want to work for a company where who you are is valued and respected, we’d love to hear from you.

#WeAreTT #BeMeAtTT

TT Electronics does not accept any unsolicited resumes from third parties. Any resumes submitted by a third party for this or any other position will not be subject to any recruitment fees if hired.