Manufacturing Engineer II

BioTalent Ltd; Huntington Beach (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the medical device sector is seeking a Manufacturing Engineer II to enhance manufacturing processes for implantable devices. This role involves significant collaboration with internal and external teams, focusing on quality improvement and cost reduction initiatives. The ideal candidate will possess strong engineering skills and a willingness to travel extensively.

Qualifications

• 3-5 years of manufacturing experience, preferably in medical devices.
• Strong knowledge of ISO 13485 and FDA regulations.
• Experience with Design of Experiments or optimization methods.

Responsibilities

• Develop, analyze, improve, and validate manufacturing processes for polymeric implantable devices.
• Manage internal and external resources to reduce costs and improve efficiency.
• Participate in failure analysis and corrective action activities.

Skills

Process characterization

Validation

Problem-solving

Communication

Organizational skills

Education

BS in Mechanical or Manufacturing Engineering

MS in Mechanical or Manufacturing Engineering

Tools

pFMEAs

MVP

IQ/OQ/PQ/PPQ

TMVs

Job description

Manufacturing Engineer II

Our client is seeking a highly motivated Manufacturing Engineer II to drive manufacturing process analysis, improvement, and validation, with a focus on implantable devices. This role will collaborate closely with management, internal engineers, and external vendors to enhance process and component quality, while also identifying cost reduction and quality initiatives to ensure long-term product value and viability. You will contribute to optimizing device design and manufacturing processes to reliably and repeatedly produce implantable components that meet design input and product specifications.

Located in Orange County, we are looking for a hands-on individual with exceptional communication, organizational, problem-solving, and technical skills, and a willingness to travel both nationally and internationally. Due to outsourced manufacturing, significant national travel to supplier sites (up to 50% of the time) is required. The ideal candidate will thrive in complex and ambiguous environments, while maintaining a clear understanding of the overall project goals.

Responsibilities

1. Develop, analyze, improve, and validate manufacturing processes, focusing on polymeric implantable devices.
2. Identify, design, install, and validate equipment.
3. Manage internal and external resources to reduce costs and improve supply chain efficiency.
4. Validate processes using statistical process analysis.
5. Develop test plans to define acceptable tolerance ranges that meet design input and product output specifications.
6. Create and optimize work instruction documentation for manufacturing and assembly.
7. Define product output specifications related to manufacturing processes.
8. Plan, schedule, conduct, and coordinate detailed phases of manufacturing work.
9. Support scheduling, ordering, vendor relations, and internal manufacturing environment management.
10. Participate in failure analysis and corrective action activities to guide design and process modifications.
11. Provide technical liaison, coordination, and collaboration with technicians.
12. Support risk analysis, requirement definition, and regulatory submissions.
13. Support and manage process risk analysis, including key suppliers.
14. Assist in requirements definition.
15. Provide input and support for regulatory affairs regarding process or material changes.
16. Support design for manufacturing reviews in cooperation with internal engineers and key vendors.

Requirements

• BS in Mechanical or Manufacturing Engineering (essential), MS desirable.
• 3-5 years of manufacturing experience, including process development and Manufacturing Engineering, preferably in the medical device industry (essential).
• Strong working knowledge of process characterization and validation, including tools such as pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs (essential).
• Understanding of medical device quality regulations, practices, and standards, such as ISO 13485 and FDA quality system regulations (essential).
• Experience with Design of Experiments or optimization methods (desirable).
• Experience in logistics and supply chain (desirable).
• Experience in the synthesis and processing of polymers (desirable).
• Experience with cleanroom manufacturing and cleanroom installation and setup (desirable).