Company Summary: Regenesis Biomedical is a medical device company based in Scottsdale, Arizona, with a 28-year history of advancing pain therapy technologies that significantly improve patient outcomes. Our mission is to alleviate pain, restore health, and improve quality of life through cutting-edge, non-invasive medical solutions. Recognized as a leader in the pain management space, we are committed to innovation, integrity, and compassionate care. At Regenesis, we cultivate a collaborative and dynamic work environment where every team member plays a vital role in driving progress. We?re proud to offer opportunities for personal and professional growth, supported by comprehensive benefits and a strong emphasis on work-life balance. As we continue to grow and expand our reach, we remain dedicated to pushing the boundaries of our therapies on new disease states and making a lasting impact on patients' lives. Join us in shaping the future of healthcare and be part of a team that?s truly making a difference. Position Summary: As a Product Engineer at Regenesis Biomedical, you will collaborate with contract manufacturers and internal teams to identify, prioritize, and resolve product issues across the portfolio, focusing on risk-based improvements. You will lead cross-functional projects aimed at enhancing product quality, regulatory compliance, cost efficiency, and patient outcomes, leveraging your expertise in electrical engineering and coordinating with external design firms for comprehensive product enhancements. Additionally, you'll manage product data, implement statistical process controls, and maintain thorough documentation to ensure regulatory compliance and inform future product development. Key Responsibilities: Collaborate with contract manufacturers and internal production teams to systematically identify, prioritize, and resolve product issues across the released product portfolio. Apply risk-based prioritization to improvements, ensuring high-impact and high-risk items are addressed first. Lead initiatives to enhance product and production performance, with a focus on improving quality, regulatory compliance, cost efficiency, delivery timelines, and patient outcomes. Manage projects of varying scope, coordinating resources and timelines effectively. Utilize subject matter expertise in key areas such as electrical engineering while coordinating with contract design firms for expertise in other areas like software and mechanical engineering to drive comprehensive product improvements. Leverage existing product databases to analyze key input and noise factors for the product. Identify additional variables for evaluation, and work with IT team to pull relevant information into product database. Implement and maintain Statistical Process Control (SPC) charts to proactively monitor product performance and inform data-driven decisions. Apply in-depth knowledge of current product performance to guide and inform other members of the team working on next-generation devices, ensuring lessons learned are applied to future development efforts. Manage and update all relevant product documentation, including design specifications, test plans, regulatory compliance records, and Bills of Materials (BOMs). Ensure accuracy and completeness to support internal teams and regulatory audits.
Salary: $117K - $148K a year
Employment Type: Full-time
Qualifications
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