Role: Engineering Sr Engr R&D
Location: Irvine CA 92614 (Onsite Role)
Duration: 11 Months of contract to begin with possible extension
Job Description:
Summary:
Applies knowledge of R&D engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development internal and external device manufacturing and device distribution.
Job Responsibilities:
- Develop solutions to a variety or 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 file.
- 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; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may 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.
Skills:
- Proven expertise in 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 problemsolving organizational analytical and critical thinking skills
- Good leadership skills and ability to influence change.
- Knowledge of Design Control
- Knowledge of applicable FDA regulations for medical device industry desirable
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fastpaced environment.
- Must be able to work in a team environment including interdepartmental teams and key contact 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 environment and prevention of pollution under their span of influence/control.
Education/Experience:
- The ideal candidate requires a bachelors degree in engineering; mechanical or biomedical is preferred and 4 years experience in the medical related industry is required Or a Masters Degree or equivalent in Engineering or related field 3 years experience related industry or industry/education experience is required. Or Ph.D. or equivalent in Engineering or related field 0 years experience required.
- Handson 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 crossfunctional team and with stakeholders around the company.
- Ability to work well independently and as a member of a team is essential.
Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website