Sr. Engineer I, Process Development

Job Summary

The Senior Engineer I, Process Development (NPI) is an advanced intermediate level role capable of independently managing and executing technical projects of moderate to high complexity within the New Product Introduction (NPI) framework. This role involves applying a strong understanding of Manufacturing Process Strategies, DFM/DFA, Lean, and Six Sigma to design, develop, integrate, and validate robust manufacturing processes into the Value Streams

The Senior Engineer 1 ensures technical quality, contributes to project success, and may provide guidance to junior team members.

Job Details/Responsibilities

Technical Expertise

• Under minimum guidance designs, develops, integrates, and validates new or modified manufacturing processes in compliance with TMC Quality System requirements and regulatory standards.
• Applies advanced engineering principles and technical knowledge to process developments design and validation efforts. Possess working understanding of Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Provides guidance and mentorship to junior engineers and technicians on specific project tasks and methodologies within NPI projects.

Process Development and Innovation

• Maintain Manufacturing Process Design standards.
• Contributes to the use of Design For Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Contributes to the definition and documentation of critical process parameters (CPPs) and material specifications for new manufacturing processes.
• Contribute to assessing the proof-of-concept for manufacturing methods for NPI.
• Contributes to the execution of laboratory-polit scale processes and prototypes into scalable manufacturing processes by identifying critical process parameters (CPPs), material specifications, and equipment needs at platform level.
• Contribute to the process risk analysis (EFMEA, pFMEA) and execute process development activities including, commissioning (URS/FRS/Traceability Matrix), characterization and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards.
• Execute activities required for the acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation.
• Apply knowledge of industry's common business transaction systems (e.g., SAP, MES, Change Control, Ariba)
• Use Lean and Six Sigma tools applied to NPI processes.
• Project Planning and Execution:
• Manages technical tasks and deliverables for assigned projects, ensuring completion within scope and schedule.
• Contributes to project planning, including estimating task duration and identifying technical risks.

Design Transfer & Scale-Up

• Execute scale-up of laboratory or pilot processes to industrial production settings—including specification of equipment, methods, automation, throughput planning, and cost targets for assigned NPI projects.
• Execute under the design transfer framework for assigned projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology transfer documentation.

Cross-Functional Collaboration:

• Collaborates effectively with cross-functional teams including Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing.
• Attend project team meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication.
• Communicates technical information effectively within the project team and to immediate supervision.

Perform other job-related duties when assigned.

Job Responsibilities (continued)

Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Knowledge, Skills and Abilities (KSA)

Technical Leadership:

• Solid experience in developing, scaling, and validating manufacturing processes for medical devices or other regulated industries.
• Strong understanding of materials, equipment selection, and process technologies such as molding, joining, assembly, laser processing, or other advanced manufacturing methods used in medical device production.
• Strong understanding of Design for Manufacturability (DFM), process characterization, DOE, and statistical analysis.
• Familiarity with automation, Industry 4.0 concepts, and equipment integration a strong plus.
• Understanding of FDA regulations, ISO 13485, GMP, and risk management practices (e.g., FMEA, pFMEA).
• Experience in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred.

Communication Skills:

• Clear and effective communication of technical information within the project team and to immediate supervision.
• Proficient in preparing technical documentation.

Problem-Solving Skills:

• Strong understanding of root cause analysis, troubleshooting, and resolution of complex manufacturing and product development issues.
• Experience with tools such as Minitab, JMP, and MS Office Suite; working knowledge of CAD and PLM systems is a plus.
  

Qualifications/ Background Experiences

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Master’s degree desirable.
• 6+ years in process development, manufacturing engineering, or product development, with at least 3 years in the medical device or other highly regulated industry.
• Lean Six Sigma Green Belt (SSGB) are desirable.