LSR Principal Engineer

The Principal Engineer - LSR Process Technology is the technical authority responsible for Liquid Silicone Rubber (LSR) molding across the full medical device product lifecycle, from early concept through commercialization, sustaining engineering, and product retirement.

This role ensures LSR materials, processes, tooling, and suppliers are compliant with medical device regulatory requirements while delivering high levels of product quality, process robustness, and lifecycle cost effectiveness. Theposition partners closely with R&D, Quality, Regulatory Affairs, Operations, and Supply Chain to support safe, effective, and compliant medical device manufacturing.

Job Description encompasses the following:

1.1. Medical Device Product Lifecycle Ownership

. Provide technical leadership for LSR molding activities across all lifecycle phases:

Concept → Feasibility → Design & Development → Verification & Validation→ Transfer → Sustaining → End-of-Life

. Ensure LSR molding processes align with medical device design controls, risk management, and change management requirements

. Drive lifecycle strategies that balance patient safety, regulatory compliance, manufacturability, and cost

. Support product transitions, site transfers, and supplier changes while maintaining regulatory compliance

2.Design Control & New Product Introduction (NPI)

. Partner with R&D and Product Development teams to ensure LSR component designs comply with Design for Manufacturability (DFM) and Design for Reliability principles

. Provide expert input into:

. Component geometry, wall thickness, and sealing features

. Gate, runner, and venting strategies

. Material selection and biocompatibility considerations

. Support design reviews, feasibility assessments, and development milestones per ISO 13485 / FDA Design Control requirements

. Contribute to Design History File (DHF) documentation related to LSR molding

3.Process Development, Validation & Regulatory Compliance

. Lead development of robust, validated LSR molding processes using scientific molding principles

. Define and execute:

. Process Failure Mode and Effects Analysis (PFMEA)

. Design of Experiments (DOE)

. Process capability studies (Cp/Cpk)

. Own or approve IQ/OQ/PQ validation strategies and reports

. Ensure compliance with:

. ISO 13485

. FDA Quality System Regulation (21 CFR 820 / QMSR transition)

. ISO 14971 risk management principles

. Support audits and regulatory inspections as an LSR process subject matter expert

4.Sustaining Engineering & Post-Market Support

. Serve as escalation point for complex LSR molding issues affecting product quality or regulatory compliance

. Lead root cause analysis, CAPA investigations, and process improvements for molded components

. Support post-market surveillance activities related tomanufacturing performance

. Drive defect prevention, yield improvement, and process stability for released products

5.Change Management & Documentation

. Review and approve LSR-related changes through formal Engineering Change Orders (ECO/ECR) within the company PLM system

. Ensure changes are properly assessed for regulatory impact, risk,and validation requirements

. Act as technical gatekeeper for LSR-related lifecycle changes

6.Supplier & Contract Manufacturing Oversight

. Provide technical leadership to molders, toolmakers, and material suppliers supporting medical devices

. Support supplier qualification, audits, and technical capability assessments

. Collaborate with Quality and Supplier Management teams to address non conformances and continuous improvement

. Lead or support technology transfers between internal and external manufacturing sites

7.Technology Strategy & Innovation

. Evaluate and introduce advanced LSR technologies, automation, and digital process controls suitable for medical devices

. Drive adoption of new materials and process innovations while ensuring biocompatibility and regulatory compliance

. Maintain an LSR technology roadmap aligned with medical product pipeline and long-term business strategy

8.Technical Leadership & Mentorship

. Act as the organizational Subject Matter Expert (SME) for LSR molding in medical device applications

. Mentor engineers in scientific molding, validation, and lifecycle best practices

. Provide cross-functional technical guidance to Engineering,Quality, Regulatory, and Operations teams

. Present technical recommendations to senior leadership during program and investment decisions

Qualifications

. Bachelor's or Master's degree in Mechanical, Materials, Polymer,or Biomedical Engineering

. 10+ years of experience in LSR molding, with direct application in medical device manufacturing

. Strong experience with medical device regulations andquality systems (ISO 13485, FDA QSR/QMSR)

. Proven expertise in process development, validation (IQ/OQ/PQ),and sustaining engineering

. Experience supporting audits, inspections, and regulated change management

. Strong analytical, documentation, and cross-functional communication skills

. Strong knowledge of LSR materials, tooling design, automation, andprocess control

. Excellent analytical, problem-solving, and technical leadershipskills

. Experience in regulated industries (medical, automotive, electronics, or similar)

. Experience with enterprise PLM systems (e.g., Windchill,Teamcenter, Agile, or equivalent)

. Prior experience leading cr3oss-site or global engineering initiatives

Skills:

. Technical authority in LSR molding

. Product lifecycle ownership mindset

. Strategic and systems-level thinking

. Strong communication and influence

. Data-driven decision making

. Mentorship and team development