Systems Engineer
Description For Systems Engineer
Sentec, a Swiss-American medical device company founded in 1999, is seeking a Systems Engineer for their Sandpoint, ID facility. This role is crucial in ensuring medical device designs meet evolving regulatory guidelines and user needs. The position offers a competitive salary range of $70,000-$90,000 plus bonus, along with comprehensive benefits.
The ideal candidate will be responsible for analyzing and updating product requirements, collaborating with cross-functional teams, and ensuring compliance with medical device regulatory standards. With 3-5 years of experience required, this role offers an opportunity to directly influence product quality and make a difference in patient care worldwide.
Sentec specializes in respiratory care, utilizing advanced technology to provide healthcare professionals with non-invasive, continuous monitoring solutions. The company offers a supportive environment focused on employee growth and development, with benefits including medical, dental, vision insurance, 401K matching, paid parental leave, and educational support.
This position is perfect for an experienced systems engineer who is passionate about healthcare innovation and wants to contribute to meaningful work that improves patient care globally. The role offers both professional challenges and opportunities for advancement in a rapidly growing company.
Responsibilities For Systems Engineer
- Analyze and update existing product requirements and designs for medical device regulatory compliance
- Collaborate with cross-functional teams to identify and resolve requirement-design gaps
- Work with manufacturing, quality, and regulatory teams to implement design improvements
- Ensure compliance with regulatory and quality standards
Requirements For Systems Engineer
- Bachelor's degree in engineering, biomedical engineering or related field
- 3-5 years of experience in medical device design or systems engineering
- Knowledge of medical device regulatory standards (ISO 13485, ISO 10993, FDA 21 CFR Part 820, IEC 60601)
- Experience with risk management methodologies (FMEA and ISO 14971)
- Strong verbal and written communication skills
- Analytical mindset and strong attention to detail
- Ability to work independently
Benefits For Systems Engineer
- Competitive salary plus bonus
- Medical insurance
- Dental insurance
- Vision insurance
- HSA
- FSA
- 401K matching
- Paid parental leave
- Wellness stipend
- Tuition reimbursement
- Professional and personal growth opportunities
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