Product Engineer I
BIOTRONIK
Product Engineer I
Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company's core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.
We are seeking a motivated Product Engineer to support high-quality microelectronics for implantable medical devices, with a focus on failure evaluation and customer escalation, change management to internal and customer documentation, and material review coverage. The role spans the manufacturing lifecycle, including root cause analysis, corrective actions, and continuous improvement, while collaborating cross-functionally and progressively taking on customer ownership. Additionally, the position supports development of tools and reporting solutions and requires strong problem-solving, communication, and ownership to drive results.
Your Responsibilities
- Support new product introductions (NPI) to ensure designs meet performance, manufacturability, and quality standards.
- Drive enhancements to digital and factory tools (e.g. MES, BO/Qlik, AI solutions) to improve quality, efficiency, and data visibility.
- Advance failure analysis capabilities, targeting streamlined and increasingly automated processes.
- Perform root cause analysis on production test failures and drive timely corrective actions to support shipment schedules.
- Support customer engagement by addressing product performance issues, including failure analysis, escalation, and resolution.
- Manage product configuration and change control (BOM/DMR, SOP/WIN, customer documentation) to ensure continuity of supply and compliance.
- Oversee all aspects of product configuration management to enable continuity of supply while maintaining compliance with customer requirements including compliance with regulatory standards.
Required Qualifications
- Bachelor's degree in Electrical Engineering, Computer Engineering, or a related technical discipline.
- Strong verbal and written communication skills with the ability to collaborate across all levels; proficiency in Microsoft Windows, Microsoft Office, and standard network/email systems.
- Demonstrated experience in electrical circuit analysis and troubleshooting.
Preferred Qualifications
- 1+ years of experience (or relevant internship experience) in an electronics manufacturing or engineering environment.
- Working knowledge of statistical process control, design of experiments, structured problem-solving, and design for manufacturability.
- Ability to develop data analysis and reporting tools (e.g., Business Objects, Qlik, or similar platforms) to improve visibility and decision-making.
- Experience working within a regulated quality system (e.g., medical device environment, ISO 13485 preferred).
- Experience leveraging AI tools or digital solutions to improve efficiency, streamline workflows, and enhance data analysis.
Physical Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer for extended periods of time and communicate with co-workers.
- Must be able to travel to other office locations.
Travel Requirements
- Must be able to to travel internationally and domestically, less than 5% of the time.
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