Employment Type : Full-Time
Job Title: Sr. Manufacturing Engineer Department: Operations Reports To: Vice President of R&D Position Summary: · Responsible for process enhancement and design of process equipment to facilitate production of high quality medical instruments while achieving cost reductions milestones for assembly operations in accordance with GMP, ISO 13485, FDA QS Regulations, MDD 93/42 EEC and Canadian Medical Devices Regulation. Must have manufacturing transfer experience. Authorities: · Has authority to stop production when production equipment or process adversely affects product quality. Duties and Responsibilities: · Design and develop manufacturing processes, process instructions, and tooling/fixtures to achieve zero defect level as well as low product cost. · Create and maintain tool drawings and manufacturing documentation in coordination with the Quality Assurance and R&D. · Work cross-functionally to coordinate new design transfer and pilot production of new or updated products. · Develop and execute process validation plan. · Design and implement validation protocols for all process changes. · Work cross-functionally for technology transfer and manufacturing transfer to Contract Manufacturer. · Support hands-on prototype and pilot production of new products, product changes, and enhancements. · Work cross-functionally to ensure that products under development are manufacturable. · Procure and oversee outside vendors and consultants as required. · Provide on-going support to Contract Manufacturer for production related issues. · Create, review, and approve design change (DCOs). · Maintain accurate documentation of concepts, designs, and processes. · Maintain current knowledge of medical, technical, and biomedical developments as related to company products. · Maintain GMP systems, including pre-production quality assurance as well as post-production GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions. · Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations. · Perform all tasks while in compliance with the Company’s Quality System. Position Requirements: Technical Expertise · Experience leading process validation activities · Experience leading manufacturing transfer to contract manufacturer · Capable to lead and manage complex projects concurrently. · Proficient in analyzing, discussing, and presenting complex problem in writing or verbally. · Able to perform tolerance engineering analyses for design or process. · Able to create, prototype, and finalize new processes and associated fixtures. · Familiar with machining and molding process Design Control Expertise · Familiar with Design Control process. · Experienced in medical device industry: 510(k) experience highly preferred - PMA products helpful. · Able to generate, review, and finalize documents such as PFMEA, MVP, Validation Protocols, etc. · Familiar of GMP, ISO 13485, FDA QS Regulations, MDD 93/42 EEC and Canadian Medical Devices Regulation. General Expertise · Experienced in using SolidWorks (sheet metal, complex assemblies, drawing nomenclature) · Able to use standard machine shop equipment. · Proficiency with CAD software is required (Solid Works) · Proficiency with MS Word, Excel, Project. Education Requirements: · BSME or related discipline Experience Requirements: · 7+ years of experience in manufacturing process engineering in Medical Device field. Special Requirements: · Able to travel (estimated 25% of the time when traveling is safe). Preferred Requirements: · Experience in Statistical analysis of complex data using Minitab. · Advance knowledge in SolidWorks simulation and tolerance stack-up analysis. · Strong understanding of Product Development process and Quality engineering in general. · Experience in developing disposable device · Experience in RF technology products Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Job Type: Full-time Pay: Up to $150,000.00 per year Benefits: Schedule: COVID-19 considerations: Education: Experience: Company's website: Work Remotely:
All employees are required to wear masks when outside their workspace. Social distancing is enforced.