Job DescriptionThe Engineer II, Sustaining R&D & Value Engineering is responsible for supporting the lifecycle management, continuous improvement, and cost optimization of commercialized medical devices. Working under the guidance of senior engineers and technical leaders, this role contributes to sustaining engineering activities, business continuity initiatives, and value engineering projects that improve product quality, manufacturability, reliability, and overall product value while maintaining compliance with applicable regulatory and quality system requirements.
The Engineer II participates in the evaluation, development, verification, and implementation of product and process changes, including material substitutions, supplier transfers, component obsolescence mitigation, and design-for-excellence (DFX) initiatives. The position collaborates closely with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Supply Chain, Procurement, and Operations to identify opportunities, assess technical risk, and execute engineering solutions that support business objectives.
This role is expected to perform technical analyses, support design verification and validation activities, develop engineering documentation, investigate product and manufacturing issues, and contribute to annual cost savings and business continuity goals. The Engineer II applies engineering fundamentals and problem-solving skills to execute projects with increasing independence while continuing to develop technical expertise within assigned product families and technologies.
Key Responsibilities- Assist with sustaining engineering efforts for products already available on the market.
- Complete Value Analysis/Value Engineering (VAVE) projects focused on cost reduction and operational efficiency.
- Develop and implement design changes to improve manufacturability, quality, reliability, and supply continuity.
- Support material qualifications, supplier changes, and component substitutions.
- Perform engineering analyses, root cause investigations, and risk assessments.
- Author and maintain design control documentation, technical reports, engineering justifications, and change records.
- Support Design Verification (DV), Design Validation (DVal), and testing activities.
- Work together with diverse groups to guarantee effective project implementation and adherence to regulations.
- Assist in identifying and developing opportunities for product cost savings and business continuity improvements.
- Drive assigned projects to meet quality, schedule, and business objectives.
What Makes You a Great FitWe are looking for a proven engineer who thrives in a collaborative and inclusive environment. The ideal candidate will possess:
- A Bachelor's degree in Engineering or a related field.
- 3-5 years of experience in engineering roles, preferably in the medical device industry.
- Strong analytical and problem-solving skills.
- Proven background in VAVE projects and ongoing engineering support.
- Excellent written and verbal communication skills.
- Ability to strictly adhere to regulatory standards and quality processes.
- Proven track record of successfully implementing design changes and improvements.
- Strong collaboration skills and the ability to work effectively with multidisciplinary teams.
Primary Work LocationUSA CA - Irvine Laguna Canyon
Salary Range Information$105,500.00 - $168,800.00 USD Annual
