Staff R&D Engineer, Sustaining

Imperative Care • Campbell, CA

10d • Onsite

About The Position

As an advanced professional in this field, the Staff R&D Engineer is responsible for conceptualization, design, development, and manufacturability of endovascular/neurovascular new products along with improvements to current product features. This position uses advance expertise and deep technical knowledge to design innovative new products and solutions that advance product development initiatives in one of the specific engineering focuses mentioned below. This role determines best course of action to solve complex situations and serves as the R&D lead on cross-functional project teams, mentoring other junior R&D engineers to contribute to their development. Drive innovation and ensure products achieve best-in-class performance while promoting manufacturability and meeting cost targets. Use advanced expertise to work directly with customer representatives, marketing, physicians, pre-clinical engineering, and regulatory affairs to understand user interactions, identify product opportunities, and develop comprehensive product requirements. Lead design-focused risk analysis activities, product verification and validation test planning, and oversee product test development and execution. Research and advise on new vendors, materials, and/or processes. Play a key technical role in a project team, evaluating assigning appropriate R&D engineering resources to meet project milestones. Lead cross-functional project team to ensure products are designed, developed, and manufactured in compliance with customer needs, company quality systems, budget, schedule and regulatory requirements of the countries into which the products will be marketed. Oversee that technical activities are properly documented and work together with process development to create manufacturing processes for a successful product transfer to manufacturing. Travel to third-party facilities and industry conferences as required.

Requirements

• Bachelor’s degree in engineering, or related discipline and a minimum of 8 years of related experience developing flexible medical device instruments; or equivalent combination of education and work experience in related regulated industry.
• Statistical analysis Software (Minitab or similar) and CAD (Solidworks, ProE, similar).
• Demonstrated knowledge of and exposure to product testing and data collection.
• High level of expertise with Product Lifecycle Management from proof of concept through manufacturing transfer including documentation control systems and design.
• Experience working under quality systems designed to meet governmental regulations such as FDA, GMPs, QSR, ISO 13485/9001, and the MDD.
• Experience leading a technical cross-functional team through all phases of product development. Strong understanding of braiding, laminating, coiling, and laser cutting design and process constraints.
• Ability to be self-directed with minimal direction and supervision and take initiative to discern from multiple priorities when guiding a technical project team toward efficient solutions and opportunities; ability to multi-task efficiently in a fast-paced environment.
• Entrepreneurial spirit, a strong foundation in documentation and communications skills required.
• Ability to work collaboratively in a team setting with strong interpersonal skills.
• Ability to travel domestically and internationally.

Nice To Haves

• MS in Engineering and experience in medical device development in a start-up environment preferred.

Responsibilities

• Conceptualization, design, development, and manufacturability of endovascular/neurovascular new products along with improvements to current product features.
• Drive innovation and ensure products achieve best-in-class performance while promoting manufacturability and meeting cost targets.
• Work directly with customer representatives, marketing, physicians, pre-clinical engineering, and regulatory affairs to understand user interactions, identify product opportunities, and develop comprehensive product requirements.
• Lead design-focused risk analysis activities, product verification and validation test planning, and oversee product test development and execution.
• Research and advise on new vendors, materials, and/or processes.
• Play a key technical role in a project team, evaluating assigning appropriate R&D engineering resources to meet project milestones.
• Lead cross-functional project team to ensure products are designed, developed, and manufactured in compliance with customer needs, company quality systems, budget, schedule and regulatory requirements of the countries into which the products will be marketed.
• Oversee that technical activities are properly documented and work together with process development to create manufacturing processes for a successful product transfer to manufacturing.
• Travel to third-party facilities and industry conferences as required.

Benefits

• Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees