Sr. Manufacturing Engineer

Overview: The Sr. Manufacturing Engineer is responsible for introducing and supporting the manufacturing of product that serves the company's commercial objectives. This role includes leading transfer to manufacturing of new product introductions, line extensions, and sustaining engineering responsibilities. This individual will work with internal teams and external contract manufacturing partners to achieve efficient and high quality production with conformance to industry and company standards and practices. The Sr. Manufacturing Engineer is integral to the successful development, launch, and sustained production of market-leading ophthalmic medical device products.

This role will contribute to the company by growing value in commercial products and new product introductions, and thereby requires an individual who is passionate, results-driven, detail-oriented, innovative, a strong communicator, and who nurtures a culture of professionalism.

Responsibilities:

• Collaborate closely with R&D and other company functions to define manufacturing requirements and enable processing capability to meet company goals for new product introductions
• Develop, transfer, and mature processes to support robust and high-volume manufacturing using lean manufacturing principles and continuous improvement
• Implementation of design and process improvements, with innovative solutions for product enhancements, cost reduction, scaling production, and consistently ensuring high quality product with very low complaint rates and high production yield. Produce robust documentation to support these endeavors in a timely fashion
• Manage external manufacturing teams, with effective direction and clarity on responsibilities, controls, and timeline
• Support the Quality agenda with QMS improvements, and the introduction of changes using a comprehensive risk-driven approach and meaningful evidence
• Develop test methods and protocols, and conduct DOEs to inform decisions and produce data-driven results
• Analyze data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports
• Identify and establish relationships with new suppliers to achieve improvements in performance, cost, or quality. Participate in supplier and subcontractor selection, qualification, and CAPA efforts
• Develop fixtures or equipment to reduce processing risk and optimize production performance
• Generate detailed component & assembly drawings to achieve design specifications that satisfy product requirements
• Achieve optimal commercial performance by investigating and addressing customer feedback
• Contribute to the overall intellectual property position of the Company
• Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to the Company's interests
• Support company goals and objectives, policies, and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements
• Actively work to promote team building and morale within the department
• Carry out all duties and responsibilities as assigned by the Company in accordance with Company policies, procedures, and applicable laws and regulations governing our business practices
  
  
  

Skills/Qualifications:

• Engineering degree in biomedical, mechanical, or equivalent work experience and training
• Minimum 5 years of related experience in the medical device industry
• Experience introducing new products to the market
• Experience in supporting external production of a high-volume medical device, including both electronic HW/SW products and single use devices
• Able to independently create and update manufacturing documentation for a commercial medical device product (MPIs, LHR, BOM, flowchart, etc)
• Familiar with DFM including injection molding , tolerance analysis and common fabrication processes.
• Experience with process validation, GMP, and state-of-the-art manufacturing processes.
• Lean Manufacturing experience and continuous improvement methodologies highly preferred
• Strong familiarity with medical device risk management and design control procedures
• Thorough understanding of regulatory requirements and guidance
• Experience with pre-commercial as well as commercial medical device manufacturing.
• Experience with product design using CAD modeling, prototyping, testing.
• Ability to exercise sound decision-making and good judgment consistent with a senior-level position.
• Strong communication skills
• Proficient in generating content in Word, Excel, SolidWorks, and PowerPoint. MS Project and statistical analysis software are a plus.
• Self-starting and proactive approach to work and growth
• Low to medium travel

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For California, the base salary range for this position is $145,000-$196,000 (highly qualified) a year. The Company maintains highly competitive, performance-based compensation programs.