Overview: With a strong technical background in medical devices, Senior Engineer, R&D ushers 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 and involving engineering teams from other functional areas (i.e., manufacturing, service). This role performs mechanical design, complex hands-on, and simulated testing for design verification and test method developments. This role produces reviews and edits engineering documentation related to assigned projects, such as technical reports, work instructions, and method and process validation. Applies knowledge in mechanical design, drug delivery systems, coatings, statistical, geometric formulas, and advanced tool engineering data to develop product configurations. Leads moderately complex engineering operations and scientific evaluation on new products, technology concepts, and product development. 

Responsibilities: 

•  Collaborate to complete product lifecycle from design concept to design transfer while ensuring the product vision is realized through execution of design control process
• Design and develop new mechanical delivery system products as well as product changes and enhancements which are consistent with a zero-defect level and low product cost
• Responsible for planning and execution of engineering design qualification testing, develops test approach/methods, writes and performs test protocols, and writes reports while ensuring completeness, accuracy and testability of product
• Complete projects (including product enhancements) working with 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 intellectual property position of the company 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 in mechanical engineering, biomedical engineering, or equivalent education and experience
• 7+ years’ experience with a BSME or equivalent or 5+ years’ experience with a Master’s degree
• Experience in the medical device industry is required
• Strong background with injection molding component designs and terminally sterile product and packaging design
• Expertise 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
• Strong background in design control processes for delivery systems, implant design and preclinical implant testing
• 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 within the ophthalmic medical device industry is desired
• Experience working with animal or cadaver tissue
• Hands-on work building prototypes to evaluate design concepts and test functionality involving assembling components, gluing, soldering, wiring, and using various lab tools (e.g. microscope, etc.) and fabrication equipment (e.g. Dremel, drill, etc.)
• Perform work in a laboratory setting conducting experiments, analyzing data, and developing new methodologies, setting up and operating equipment, conducting measurements, and handling materials
• Office work typical desk setup (sit/stand)
• Travel <25%

For California, the base salary range for this position is $107,700-$176,900 (highly qualified) a year. The Company maintains highly competitive, performance-based compensation programs. 

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)

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