Medical Device Systems Engineer, Neuromodulation

We are looking for an engineer to join Biotronik’s emerging Neuromodulation Technical Segment, supporting system engineering for active implantable neuromodulation devices. This role is at the technical center of development of complex implantable medical devices. The role involves collaboration across multidisciplinary teams including software, electronics, mechanical and digital health. This role involves contributions from prototype phases through verification and validation, all the way to post-market product support.

Your Responsibilities

System Engineering and Development

• Design and Integration of complex medical systems, ensuring seamless interaction between software, hardware, and digital health components.
• Prototype Development: Collaborate with cross-functional teams to develop and refine prototypes, incorporating new technologies and methodologies.
• Testing and Validation: Support development of adequate test plans to ensure all system components meet quality and performance standards.
• Technical Leadership: Provide expertise in systems engineering principles to guide project teams through the design and development lifecycle, including triage of technical and business risks.
• Comply with medical device regulations: Contribute that all development activities in responsibilities of systems engineering comply with medical device regulations.
• Risk Management: Support and lead activities related to risk management e.g. FMEA, root cause analysis, system hazard analyses and technical item triage.
• Safety Standards Compliance: Maintain up-to-date knowledge of relevant safety standards (e.g., IEC 60601, ISO 14971) to help ensure all products meet these requirements.

Post-Market Support and Continuous Improvement

• Product Support: Provide engineering support for products in the market, addressing technical issues and implementing enhancements.
• Complaint Analysis: Conduct in-depth analysis of devices returned as part of formal complaints. Conduct investigations to reproduce issues.
• Data Analysis: Utilize data science techniques to analyze product performance and field data, driving improvements and innovations.
• Stakeholder Collaboration: Work closely with external and internal teams to align product development with market needs and regulatory expectations.

Your Profile

Education / Experience Requirements

• Bachelor's Degree or higher in a technical field such as BioMedical Engineering, Electrical Engineering Computer Science, Data Science or a related discipline.
• Industry Experience: 5 years of engineering experience preferred, with a strong emphasis on medical or other highly regulated industry.

Additional Preferred Knowledge, Skills and Abilities

• Proficiency in at least one data processing, scripting, and plotting software (e.g. VS Code, Matlab, python).
• Some experience in rapid prototyping of electronics (e.g. Raspberry Pi, Arduino).
• Experience working with regulatory standards such as IEC 60601, FDA 820.11, MDR and ISO 14971
• Data science experience, statistical analysis, and ML preferred.
• Experience working in requirements management systems.
• Experience working with software Dev Ops tool suites like Azure DevOps, JIRA, Git.
• Project Management Skills: Proven ability to organize, prioritize, and execute multiple projects in a fast-paced, detail-oriented environment.
• Communication & Teamwork: Strong interpersonal and communication skills, with the ability to effectively collaborate across teams and present complex ideas clearly.
• Ability to prioritize effectively and work on concurrent projects.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills including technical report writing skills.

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 work a minimum of 40 hours / week.
• Must be able to travel to other office locations.

Location

• Lake Oswego, OR this is a hybrid position.

Travel Requirements:

Must be able to travel internationally and domestically, less than 10% of the time.

About MSEI:

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.

EEO Commitment:

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.