Principal Systems Engineer

Principal Systems Engineer
Maple Grove MN Direct Hire $160000$190000 (Flexible) Onsite

We are seeking a highly skilled Principal Systems Engineer to join our clients growing team. This role is focused on the design and development of complex electro-mechanical systems including system architecture integration and supporting documentation in compliance with regulated quality system requirements. The ideal candidate will serve as a technical leader collaborating with cross-functional teams and acting as a key technical interface with customers to ensure that system-level requirements and project deliverables are successfully met.

Key Responsibilities

• Define and manage system-level requirements assisting customers in translating user needs into detailed engineering specifications.
• Contribute to risk management planning including the creation review and documentation of risk analyses and hazard assessments.
• Ensure product verification and validation activities are executed with complete traceability to requirements.
• Lead and coordinate system-level analyses including modeling simulations and algorithm development.
• Act as the primary technical point of contact for assigned projects managing technical scope and deliverables.
• Facilitate cross-disciplinary technical discussions driving alignment and collaboration across engineering teams.
• Guide system architecture development and oversee system integration throughout the product lifecycle.
• Participate in design reviews to ensure compliance with system requirements and quality standards.
• Support the reuse of proven technologies to streamline development and improve efficiency.
• Provide input on technical training tools and process improvements to support the systems engineering function.
• Identify and contribute to the protection of intellectual property developed within the engineering team.

Qualifications

• Bachelors degree in Engineering Computer Science or related technical field required; Masters degree preferred.
• 10 years of experience in systems engineering ideally within the medical device industry or other regulated industries.
• Familiarity with system design standards such as IEC 60601 ISO 13485 ISO/EN 14971 and IEC 62304.
• Experience with requirements management tools preferred.
• Proficiency with modeling and simulation tools (Matlab Simulink or similar) is desirable.
• Knowledge of FDA submission processes (510(k) PMA De Novo) considered a strong asset.
• Experience developing Class II and III medical devices is highly advantageous.
• Excellent communication leadership and problem-solving skills.

Benefits

• Comprehensive healthcare coverage including medical dental and vision.
• Retirement plan with company match.
• Generous paid time off (PTO) personal days and a birthday holiday.
• Company-subsidized wellness and fitness resources.
• Life insurance (basic voluntary AD&D).
• Paid family leave (maternity and paternity).
• Short-term and long-term disability coverage.

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Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin sex sexual orientation gender identity age status as a protected veteran status as a qualified individual with a disability or any other protected class status.

Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.

Required Experience:

Staff IC