Senior Product Development Engineer

Website EndoSound

The Future of EUS

Senior Product Development Engineer

 

EndoSound, an emerging medical device company, is aggressively focused on global expansion of patient and provider access to Endoscopic Ultrasound technology (EUS). With our patented design, EndoSound is able to transform any upper flexible endoscope into a fully functional EUS scope. We were recognized by the Food and Drug Administration (FDA) in July of 2021 by granting us the Breakthrough Device Designation! With our seasoned team of leaders who have a proven track record of bringing new medical devices to market, we are excited to be expanding our engineering team with a Senior Product Development Engineer who will play a key role in our mission to change where and how EUS is performed worldwide.

 

As our Senior Product Development Engineer, you will work through all phases of the development of our device, from concept generation to product launch. We are looking for someone excited to join an early-stage medical device company.  In this high-impact role, you will lead  all engineering activities including the design, development, and manufacturing process for EndoSound products. You will work with all team members to understand customer and market requirements to plan product improvements. This role will also lead efforts around device testing, design iteration, verification and validation and will support regulatory, quality and commercialization activities. Impact is our goal and we will look to the Senior Product Development Engineer to bring innovative ideas around new products and process improvements to ensure quality and cost efficiency.

This position is based in Portland, Oregon.

 

Responsibilities Include:

●       Lead full lifecycle engineering efforts as a key member of the Endosound team

●       Support Design Verification and Design Validation activities such as developing protocols, performing testing, analyzing results, and authoring completion reports

●       Work with external manufacturing partners to ensure design for manufacturability and cost efficiency

●       Manage design reviews and contribute to peer design reviews

●       Prepare engineering change documentation

●       Oversee design analysis efforts to determine critical trade-offs and to optimize system performance

●       Ensure implementation and rigor of design control best practices with compliance to EndoSound quality policies and procedures through appropriate communication, training, and education of sound quality assurance principals.

●       Supervise and participate in the maintenance of Design History Files

●       Write and maintain engineering requirements and associated design documentation

●       Develop and maintain risk hazard analysis plan and report

●       Contribute to the strategic and product planning process by providing input based on industry knowledge and experience

●       Occasional travel to manufacturing partners and other locations

 

Requirements:

●       Bachelor’s degree in Biomedical Engineering, Electrical Engineering or related

●       10+ years as a product development engineer in medical device manufacturing industry

●       Strong familiarity with ultrasound device, gastrointestinal device and/ or endoscopic device development highly desired

●       Experience leading full lifecycle medical device development from inception to completion

●       Ability to work in dynamic, fast paced environment with a comfort level in providing creative critical thought when pivoting is needed for the business or the product

●       Exhibit a flexible mindset and skillset to perform work at all stages of the product development lifecycle

●       Demonstrated comfort level working independently or with a team and  to effectively and consistently communicate all issues, ideas, and wins

●       Strong experience with various manufacturing processes, including injection molding, thermoforming, machining, micro soldering and plastics assembly

●       Undaunted with troubleshooting electromechanical systems to ensure consistent progress is made in product lifecycle

 

Technical Qualifications:

●       Experienced with leveraging statistical methods and analytical software (eg, ANOVA, DOE, Capability Analyses, Minitab, etc)

●       Strong familiarity with medical device standards including:

○       21 CFR 820 and ISO 13485: 2016

○       IEC 60601

○       IEC 62366 highly preferred

○       Risk Assessment and FMEA processes

 

You’re a Great Fit if You’re Someone Who:

●       Thrives and takes initiative in a fast-paced startup environment, remaining calm with frequent pivots in priorities

●       Passionate about contributing to our culture and mission

●       Possesses excellent analytical and organization skills, the ability to meet deadlines, a sense of urgency, and attention to detail while seeing the big picture

●       Is comfortable collaborating with both creative and technical teams, flexing between product details and customer needs

●       Is a self-starter who can be scrappy and get things done with limited resources; comfortable with the ambiguity and undefined processes at an early stage startup

●       Displays a thoughtful, considered, and compassionate approach to your work and colleagues

●       Has a passion for mentoring and encourages team growth by sharing your knowledge, skills, best practices, etc.

●       Brings an “owner” mentality and is a natural leader who can bring together cross-functional stakeholders to reach a consensus

 

 

 

To apply for this job email your details to kristin.recruiter.mckinney@gmail.com


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