Manufacturing Engineer Shift A Lead
hace 1 mes
Nextern seeks a seasoned Manufacturing Engineer to oversee the development and production of medical devices. This critical role requires expertise in manufacturing processes, supply chain management, and team leadership.
About the RoleThis position will be responsible for ensuring product enhancements meet customer specifications, addressing manufacturing issues, and managing product lifecycle stewardship. The ideal candidate will have experience in similar positions within highly regulated industries and possess strong organizational, problem-solving, and analytical skills.
Key Responsibilities:- Coordinate product enhancements with customers and internal project teams
- Review high-level design requirements to evaluate feasibility within Nextern's core competency and vision
- Determine required Bill of Materials and work with supply chain to obtain pricing from internal and external vendors
- Draft proposals and cost models for review by management
- Responsible for manufacturing issues related to product quality and cost
- Support customer calls and presentations on product sustaining activities
- Generate documentation for product development and manufacturing, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembly instructions, manufacturing instructions, and procedures
- Conduct component and device testing protocols
- Accurately generate standard written reports
- Develop plans to evaluate process repeatability and stability through equipment qualification and process validation
- Work with quality, supply chain, and PD to ensure compliance with QSR and internal protocols
- Collaborate with internal manufacturing and outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification, and validation of process, tooling, and equipment
- Provide support in resolving product complaints and/or safety issues
- Facilitate pilot production of new products with various departments
- Support company goals, policies, Good Manufacturing Practices, and FDA/QSR regulations
- Transfer engineering projects from engineering into manufacturing as required
- Bachelor's degree in engineering, business administration, or related fields
- At least 3 years of experience in similar positions within highly regulated industries
- Fully bilingual Spanish-English
- Promote continuous improvement using techniques like Lean, Six-Sigma, Poka-Yoke, Error Proofing, Measurement System Analysis, Statistical Process Controls, Equipment Qualification, Process Qualification, Control Plan, and Process Failure Mode and Effect Analysis (PFMEA)
- Commitment to excellence and high standards
$90,000 - $120,000 per year
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