Duties and Responsibilities:
- Lead the development, validation, and continuous improvement of manufacturing and process technologies for medical device products in accordance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
- Serve as a senior technical resource for manufacturing and process engineering activities across multiple product lines.
- Lead complex, cross-functional projects from concept through commercialization, including new product introductions, line extensions, and transfers from R&D to manufacturing.
- Develop, qualify, and validate new manufacturing processes and equipment, including authorship and execution of IQ/OQ/PQ protocols, test method validations (TMV), and process validation reports.
- Create and maintain the process validation master plan.
- Apply statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA/Gage R&R), and process capability analysis to develop, characterize, troubleshoot, and control manufacturing processes.
- Lead risk management activities for manufacturing processes, including authorship and review of PFMEAs.
- Drive Design for Manufacturability (DFM) input during product development and design transfer activities.
- Identify, evaluate, and implement opportunities to reduce cycle time, scrap, and manufacturing cost; develop and execute plans to capitalize on these opportunities.
- Apply Lean manufacturing principles and continuous improvement methodologies to optimize production workflows, layouts, and equipment utilization.
- Lead the evaluation, specification, design, and qualification of tools, fixtures, custom equipment, and production systems to meet capability and capacity requirements.
- Monitor process output, yield, and scrap; analyze trends and drive corrective actions to improve performance.
- Perform and oversee cleanroom (Class 8) validations as required.
- Manage activities with outside vendors and contract manufacturers providing components, assemblies, processes, testing, and other services.
- Lead investigations of nonconformances and support CAPA activities, including root cause analysis and effectiveness checks.
- Author, review, and approve standard operating procedures, work instructions, engineering change orders, and related quality system documentation.
- Train production operators and technicians on new processes and ensure adherence to process standards.
- Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485.
- May supervise and provide technical direction to engineers, technicians, and operators; mentor junior engineers and technicians.
- Present project status, technical findings, and recommendations to cross-functional teams and management.
- Maintain effective communications with supervisor, peers, and stakeholders.
- Provide strategic direction for specific projects and contribute to departmental planning.
- Support day-to-day manufacturing activities as needed.
Qualifications
Education & Certifications:
- Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.
Work Experience:
- Minimum of 10 years' experience in a medical device manufacturing environment is required.
- FDA regulated work experience required.
- Demonstrated experience leading process validations (IQ/OQ/PQ) and manufacturing process development require
Knowledge, Skills & Abilities:
- Able to read, write and understand English.
- Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485.
- Proficiency in statistical methods including DOE, SPC, MSA, and process capability analysis.
- Working knowledge of design controls, risk management, and CAPA processes.
- Familiarity with Lean manufacturing and continuous improvement methodologies.
- Strong project management and technical leadership skills.
Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Broughton
Branch Phone:
(909) 244-1777
Location:
Ontario, CA