Product Systems Engineer, Idaho

The Systems Engineer is responsible for ensuring that existing medical device designs align with evolving regulatory guidelines and user needs. The Systems Engineer will focus on updating requirements documentation, addressing design gaps, and ensuring compliance with regulatory and quality standards. This position is based in our Sandpoint, ID facility.

Essential Duties and Responsibilities:

Analyze and update existing product requirements and designs to ensure compliance with medical device regulatory and quality standards.

Collaborate with cross-functional teams to identify and resolve gaps between requirements and designs.

Collaborate with manufacturing, quality, and regulatory teams to implement design improvements per design control process and QMS standards.

Requirements

Qualifications/ Education:

Bachelor’s degree in engineering, biomedical engineering or related field required.

3-5 years of experience in medical device design or systems engineering.

Strong knowledge of medical device regulatory standards such as ISO 13485, ISO 10993, FDA 21 CFR Part 820, IEC 60601.

Experienced with risk management methodologies, including FMEA and ISO 14791.

Strong verbal and written communication skills with the ability to communicate with colleagues of various cultures and personalities across internal and external teams.

Possess an analytical mindset, strong attention to detail and be able to work independently.

Benefits

Meaningful work in a rapidly growing company with opportunity for advancement

Directly influence the quality of products and make a difference for patients worldwide

Opportunities for professional and personal growth

Salary: $70,000-$90,000 plus bonus

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave , a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you’re not just choosing a job – you’re embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide. 

is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.