Principal Process Development Engineer

• 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.

• 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.

TT Electronics