Sr Electrical Engineer

MML US Inc•San Diego, CA

About The Position

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in the United States, Australia, the United Kingdom, and Germany. The Senior Electrical Engineer will provide technical guidance and knowledge of best practices to assist with the design, development, approval, launch, and support of new and existing products Throughout the product lifecycle. The role supports both sustaining engineering efforts for commercially released products and the development of next-generation medical devices, including active implantable systems and associated accessories. The Electrical Engineer will be responsible for identifying, developing, and delivering innovative solutions in alignment with Mainstay Medical’s strategic direction and operational priorities. This includes developing a deep understanding of customer needs and translating them into functional requirements, developing specifications, conducting risk assessments, and coordinating verification and validation activities to provide safe and effective products.

Requirements

Bachelor’s degree in Electrical Engineering, Computer Engineering, or equivalent.
Minimum of 5 years of related experience (medical device industry preferred).
Experience with mixed-signal circuit design and embedded systems; firmware development experience a plus.
Required experience and skills: design, time management, technical writing, basic regulatory, basic quality, creative problem solving, medical device development and proficient computer skills (Microsoft Office products).
Practical experience working in highly regulated industries (21 CFR Part 820 and/or ISO 13485 preferred)
Experience with medical devices (active implantables preferred)

Nice To Haves

Automated Test Engineering experience preferred

Responsibilities

Apply engineering knowledge and knowledge of medical device industry to assist company in developing strategic plans for development of new products and enhancements to existing products.
Lead electrical and electromechanical design initiatives by identifying customer requirements; researching and testing manufacturing and assembly methods / materials; and soliciting observations from operators to ensure products meet internal and external quality system and business requirements.
Collaborate effectively within a multi-disciplinary engineering team and work cross-functionally with Quality, Regulatory, Marketing, and Operations to ensure alignment throughout product development.
Develop, manage, and communicate project schedules for development projects by establishing required deliverables, identifying resource requirements, and providing direction to team members.
Define new and existing design requirements and develop specifications in accordance with manufacturing, marketing, and customer expectations and requirements on products such as; implantable leads, implantable pulse generators, and implant and surgical accessories.
Direct and/or participate in risk management activities.
Direct and/or conduct the development of test methods, verification / validation activities, and documentation of outcomes associated with product development to assure system and product quality.
Prepare technical product reports by collecting, analyzing, and summarizing information and trends.
Identify and analyze design problems to formulate optimal solutions that satisfy cost and technical requirements using both internal and external technical resources.
Communicate key information and recommendations to influence technical decisions and strategy.
Generate and leverage existing and new intellectual property for new therapy and/or clinical use.
Engage in personal and continuing program of learning to broaden knowledge in areas of existing expertise and to gain knowledge in new fields of general engineering in order to improve the individual effectiveness and to avoid technical obsolescence.
Contribute to team effort by accomplishing related results as needed.
Provide technical supervision to lower-level engineers and other technical personnel including external contractors as required.
Take on additional responsibilities as identified by the leadership team of Mainstay Medical.