Sr. Process Development Engineer
Lumicity
Lead development & validation of manufacturing processes for new medical devices.
10 days ago ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Los Angeles Metropolitan Area
Onsite
Company Size
88 Employees
Service Specialisms
Energy
Sustainability
Renewable Energy
Consulting
Project Development
Engineering
Sector Specialisms
Engineering
Energy
Technology
Medical
Digital Health
Pharmaceutical
Role
What you would be doing
process development
manufacturing optimization
process validation
statistical analysis
process control
technology transfer
- Collaborate closely with R&D, Quality, Regulatory, and Manufacturing teams to ensure process scalability and compliance with FDA, ISO 13485, and GMP standards.
- Develop and optimize manufacturing processes including tooling, fixtures, automation, and equipment validation.
- Design and conduct engineering studies, test protocols, and reports (IQ/OQ/PQ) in support of product development and regulatory submissions.
- Stay abreast of emerging technologies and trends in medical device manufacturing and process automation.
- Support CAPA investigations and implement robust corrective and preventive actions.
- Execute process characterization, DOE, and root cause analyses using statistical tools (e.g. Minitab, JMP).
- Lead process development activities from concept through commercialization for new medical devices.
- Define and implement process control strategies, including PFMEA, control plans, and SPC.
- Lead or support technology transfer from R&D to manufacturing, including supplier engagement and pilot builds.
- Identify and implement cost reduction and yield improvement initiatives.
What you bring
engineering degree
10+ years
gmp
solidworks
fmea
erp/mes
- Bachelor’s or Master’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering or a related field.
- Excellent problem-solving, project management, and communication skills.
- 5–10+ years of relevant experience in process development within the medical device industry.
- Deep understanding of GMP, FDA 21 CFR Part 820, ISO 13485, and validation protocols.
- Strong experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis.
- Proficiency with CAD (SolidWorks preferred), statistical tools, and ERP/MES systems.
- Hands-on experience with medical device manufacturing processes such as molding, extrusion, assembly, bonding, or sterilization.
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Training + DevelopmentInformation not given or found
Interview process
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Company
Overview
200% growth
Department scaling
Successfully growing departments by 200% through rapid and precise recruitment efforts.
2016
Year established
Launched in 2016 as the U.S. arm of a global group, focusing on addressing technical talent gaps.
- Headquartered in Los Angeles with offices in San Diego, Houston, Miami, and Chicago, the firm has scaled effectively through strategic expansion.
- Specializes in recruiting for Engineering, Life Sciences, Technology, and Energy sectors, targeting high-growth industries like semiconductors, robotics, and medical devices.
- Operates on contract and direct-hire models, offering contingent, retained, and executive search services to meet client needs.
- Project highlights include staffing C-suite roles in oncology biotech startups, scaling digital-health engineering teams post-Series C, and sourcing cleared RF engineers for aerospace clients.
- Consultants bring industry expertise and a 'human touch,' leveraging deep domain knowledge to fill niche technical roles.
- One to One In‑Depth Introductions with an Energy Recruitment Expert
- An Extensive Network of Candidates
- A Service That Delivers The Best
- A Human Touch‑driven by meaningful partnerships
80 MW Solar
Solar Projects Funded
Developed and secured funding for significant solar projects contributing electricity for thousands of people.
£25M Heating
Biomass Heating Installation
Completed a substantial biomass-heating project across multiple sites, providing clean heat energy.
- Since 2015, expanded operations into aquaculture and horticulture with a clean-energy focus
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