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Manufacturing Process Engineer II
2 months ago
Nova Biomedical is seeking a skilled Manufacturing Process Engineer II to support the daily technical activities of planar sensor manufacturing.
Key Responsibilities:- Provide technical support to planar sensor operations, investigating and resolving issues that arise during manufacturing/processing.
- Measure and inspect components for form, fit, function, and disposition nonconforming product as required.
- Document manufacturing variances and changes, and circulate for approval.
- Update and create manufacturing documentation, including AP, TP, OI, OP, Drawings, and Artwork, in accordance with Quality System Regulations (QSR's) and ISO standards.
- Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), and Continuous Improvement Studies/Evaluations.
- Research, specify, and procure new equipment for existing or new processes/assemblies.
- Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
- Collaborate with R&D and other manufacturing engineers to develop methods/processes to scale production and implement new products.
- Train assemblers and operators regarding new processes and assemblies.
- Lead continuous improvement programs to reduce cost and cycle times of products.
- Examine and implement lean manufacturing techniques.
- Work cross-functionally with Consumable Engineering for automation and longer-term projects as appropriate.
- Bachelor's degree in Mechanical Engineering or Industrial Engineering.
- 2-4 years of experience in an ISO 13485 environment.
- Knowledge of lean manufacturing methods and practices.
- Six Sigma Green Belt (preferred).
- Hearing.
- Ability to remain in a stationary position, often standing or sitting for prolonged periods.
- Ability to wear PPE.
- Ability to travel.
- Strong interpersonal and communication skills.
- Strong project management fundamentals.
- Time management skills.
- Six Sigma.
- Lean manufacturing principles.
- Minitab (and other statistical and graphical analysis applications).
