Sr. Research and Development Engineer

Overview: With a strong technical background in medical devices, a Senior R&D Engineer, leads technical development projects and works collaboratively with project team members to develop and manage project plans and execution. This role will work on projects involving more than one engineering discipline, involving engineering teams from other functional areas (i.e. manufacturing, quality, supply chain, etc.). This role requires a strong hands-on approach to mechanical design (e.g. prototyping), problem solving and test method development. This role performs mechanical design, complex hands-on, and simulated testing for design verification including test method development. This role produces, reviews, and edits engineering documentation related to assigned projects, such as technical reports, work instructions, test methods, verification/validation protocols/reports. Applies knowledge in mechanical design, drug delivery systems, coatings, statistical analysis, geometric formulas, and advanced engineering data to develop product configurations/specifications. Leads moderately complex engineering operations and scientific evaluation of new and iterative products, technology concepts, and product development.

Responsibilities:

• Collaborate to complete the product lifecycle from design concept to design transfer while ensuring the product vision is realized through the execution of the design control process
• Design and develop new mechanical delivery system products as well as product changes and enhancements which are consistent with high production yield and low product cost
• Responsible for planning and execution of engineering design qualification testing, developing test approaches/methods, writing and performing test protocols, and writing reports while ensuring completeness, accuracy, and testability of product requirements
• Complete projects (including product enhancements) working with the Manufacturing, Clinical Affairs, Sales and Marketing, and Quality Assurance
• Responsible for development and release of engineering design documentation, inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications and provide solutions or investigate alternative design options
• Contribute to the company's intellectual property position via invention and patent applications
• Maintain accurate documentation of concepts, designs, drawings, and processes
• Engage and oversee outside vendors and consultants as required
• Encourage the development team to utilize DOE methodology and other experimental design tools. Generate effective testing reports
• Lead or contribute to the structure and content of design review meetings
• Identify and solve moderately complex problems at the product level independently and as part of a team and communicate status to stakeholders
• Operates with GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. Provide support in the resolution of product complaints and/or safety issues
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, ISO 14971, ISO 11607, and any other applicable domestic or international requirements
• Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers
• Perform other duties as assigned

Skills/Qualifications:

• Bachelor of Science degree within mechanical engineering, biomedical engineering, or equivalent education and experience
• BS, MS or PhD and 5 – 10 years experience
• Experience in the medical device industry is required
• Strong background with injection molding component designs and terminally sterile product and packaging design
• Strong background in design control processes for delivery systems, implant design, and preclinical implant testing
• Expertise in using CAD as a design tool, including creating models, assemblies, and detailed drawings, is required, Expert knowledge of SolidWorks a plus
• Design for manufacturability, i.e. product assembly, component fabrication, cost optimization
• Strong mechanical design and product development experience with drug delivery systems, drug coatings, bioabsorbable materials and nitinol are desirable
• Experience working with pharmaceutical suppliers or contract manufacturers.
• Background in 510k (Class II) and/or PMA (Class III) regulatory pathways, 21 CFR 211
• Hands-on-lab experience building and testing prototypes
• Working knowledge of the patent process
• Ability to perform computerized project scheduling
• Strong background in statistical methods
• Experience with design for human factors/usability
• Experience within the ophthalmic medical device industry desired
• Experience working with animal or cadaver tissue

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.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)