Overview: With a good technical background, an R&D Engineer works under the supervision of an R&D technical project lead to develop and execute projects involving more than one engineering discipline and collaborate with cross-functional engineering teams (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 produces and edits engineering documentation related to assigned projects, such as technical reports, work instructions, test methods, and verification/validation protocols/reports. The individual will be required to generate and edit engineering documentation related to assigned projects, such as engineering drawings, technical reports, work instructions, test methods, verification/validation protocols, and reports. Applies complex algebraic, statistical, and geometric formulas and engineering data to develop product configurations/specifications. Contributes to engineering operations and complex scientific evaluation of new and iterative products, technology concepts, and product development.
Responsibilities:
- Collaborate on the complete product lifecycle within design control from design concept to design transfer to manufacturing
- Design and develop new products as well as product changes and enhancements that supports high production yields and low product cost, solve complex problems at the product level under the supervision of R&D technical project lead
- Responsible for designing, testing and evaluating prototypes. Execution of engineering product testing, developing test approach/ methods, writes and performs test protocols, and writes reports while ensuring completeness, accuracy and testability of product requirements
- Responsible for the development and release of engineering design documentation, inspects and tests 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
- Utilize DOE methodology and other experimental design tools, generate effective testing reports
- Takes instructions on day-to-day tasks and identifies and resolves issues, and communicates status to peers and manager
- 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:
- A Bachelor of Science degree within mechanical engineering, biomedical engineering or equivalent experience
- BSME or equivalent and 0-2 years experience
- Experience with product and mechanical design
- Strong engineering background: analytic skills and analysis, scientific method, material sciences and mechanics
- Experience with SolidWorks
- Familiar with drafting standards, dimensioning and tolerancing
- Experience in the medical device industry.
- Experience with adhesive bond processes
- Experience with injection molding design and processing
- Background with terminally sterile product and packaging design
- Background in 510k (Class II) and/or PMA (Class III) regulatory pathways
- Experience within the ophthalmic medical device industry
- Experience with mechanical failure/root cause analysis
- Hands-on-lab experience building and testing prototypes.
- Experience with drafting and execution of test protocols and reports
For California, the base salary range for this position is $98,000-$133,000 (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)
