TITLE: Engineering - Process Eng – Product Development

UNIPOINT OCCUPATION ID: REVISION: Rev 01

DEPARTMENT: Engineering

POSITION OBJECTIVE: The Process Engineer (Product Development) supports process design,

development, verification, and validation activities for medical devices. This role ensures compliant and

robust process development aligned with ISO 13485, FDA 21CFR 820, and applicable regulatory and

customer requirements. The Process Engineer contributes to manufacturability, operational efficiency,

and effective design transfer to manufacturing – supporting successful product commercialization and

ongoing internal quality system performance.

DIRECT REPORTS: No

MAJOR DUTIES:

• Support process development for new products including concept trials, prototyping, DOE, and

scale-up activities.

• Develop and optimize manufacturing processes for molding, assembly, bonding, and packaging.

• Participate in DFM/DFA with Design Engineering and clients.

• Define and maintain process requirements, specifications, and acceptance criteria.

• Execute IQ/OQ/PQ validation activities including protocol authorship, execution and reporting.

• Support tooling qualification (T0, T1, FAT/SAT).

• Analyze process capability (Cp/Cpk), yield, and scrap.

• Support root-cause investigations during pilot builds and early production builds.

• Develop PFMEA, Control Plans, and process documentation.

• Collaborate with automation partners, suppliers, and client engineering teams.

• Contribute to continuous improvement to enhance robustness and efficiency.

WORKING RELATIONSHIPS: AMS, Design Eng, QA, Operations, PMO, Business Development

FUNCTIONAL COMPETENCIES:

 Results-Oriented – Delivers predictable, high-impact results across multiple workstreams and

influences planning to prevent delays, production, and quality issues.

 Analytical Expertise – Applies advanced engineering analysis to solve complex problems and

mentors’ others in technical decision-making.

 Systems-Level Thinking – Leads complex, cross-functional problem solving and provides

technical direction for challenging design and manufacturing issues. Participate or lead creation

and maintenance of risk management files.

 Critical Thinker – Makes high-quality, risk-based design decisions that influence product

safety, compliance, and manufacturing performance.

 Cross-Functional Influencer & Technical Mentor – Influences cross-functional outcomes,

mentors junior engineers and represents Engineering in technical discussions with clients and

suppliers.

POSITION REQUIREMENTS:

• Bachelor’s degree in Mechanical, Industrial, or related Engineering discipline.

• 1-5 years of process engineering (medical device preferred).

• Strong experience in molding, assembly, and process development.

• Proven experience with validation (IQ/OQ/PQ) and URS/DS/FS packages.

• Skilled in DOE, SPC, and statistical tools (Minitab, JMP)

• Excellent communication skills, able to influence cross-functional discussions with QA/RA,

Operations, PMO, Tooling, and suppliers.

• Knowledge of ISO 13485, ISO 9001, and familiarity with risk management principles (ISO

1. and design transfer.

• Ability to write technical design documents and experience preparing Design validation

protocols and reports.

• Skilled in developing and maintaining PFMEA and contributing to Risk Management Plans and

ISO 14971 documentation.

REPORTS TO: Snr Engineering Manager