Sr R&D Engineer CA
1 day ago
Position: Sr R&D Engineer, Req#: 9241-1
Location: Irvine, CA (100% Onsite)
Duration: 10+ Months Contract
Job Description:
What does your group do? We are the THV R&D Sustaining group. We support changes and improvements to commercialized products.
Does your team use any specific technology/software you want us to look out for? Microsoft Office (i.e., Word, Excel, PowerPoint, etc.), Minitab, Adobe Acrobat
Do you foresee this role being needed again? Yes
What will a typical workday look like? Workdays will vary by project. This can include drafting technical documents (procedures, protocols, reports, etc.), supporting testing in the lab, documentation technical review, transfer of test samples to and from the lab.
What will the work schedule be? Can any overtime be expected? Standard office hours with overtime only as needed when there is an urgent need. They would need to be onsite M-F.
Will there be any travel involved? None expected
Will you consider remote work? If yes, will they need to be in a specific time zone? No
What are your top 3 required technical skills? Must haves? Design Verification experience, Statistical Analysis, and technical writing.
What are nice to have skills? CAD modeling, familiarity with balloon catheters and access devices
Education and Experience:
- The ideal candidate requires a bachelor’s degree in engineering; mechanical or biomedical is preferred and 4 years of experience in the medical-related industry is required, Or a
- Master's Degree or equivalent in Engineering or related field, 3 years of experience related to industry or industry/education experience is required. Or
- Ph.D. or equivalent in Engineering or related field, 0 years of experience required.
- Hands-on experience with catheter design and the proven ability to apply technical knowledge and judgment to complex technical problems and technical proficiency specific to mechanical problem-solving in medical device design.
- Experience in catheter design (machining, extrusions, braiding, molding, and bonding processes) is required.
- Experience in new product development with successful design experience from concept to commercialization is strongly preferred.
- Effective communication, listening, and diagnostic skills, verbal and written, are necessary. The demonstration of effective collaboration and influencing skills will be key so that the candidate can achieve results within the cross-functional team and with stakeholders around the company.
- Ability to work well independently and as a member of a team is essential.
Skills:
- Proven expertise in the usage of MS Office Suite.
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
- Working knowledge and understanding of statistical techniques
- Previous experience working with test lab equipment required (if applicable)
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Strong problem-solving, organizational, analytical and critical thinking skills
- Good leadership skills and ability to influence change.
- Knowledge of Design Control
- Knowledge of applicable FDA regulations for the medical device industry is desirable
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key contacts representing the organization on contracts or projects.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.
Job Responsibilities:
- Develop solutions to a variety of problems of moderate scope and complexity.
- Brainstorm, assess and design to bring ideas to new product development. Develop, update, and maintain technical content of risk management files.
- Apply mechanical and biomedical engineering principles to the design and development of components for the delivery system.
- Drive design selection based on clinical impact, material, and supplier manufacturability. Develop test methods and procedures to evaluate device prototype performance.
- Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
- Maintain accurate documentation of concepts, designs, drawings, and procedures. Generate written protocols, reports, and technical justifications/summaries.
- Other incidental duties assigned by Leadership.
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