Konik
Principal Systems Engineer
Maple Grove, MN | Direct Hire | $160,000–$190,000 (Flexible) | Onsite We are seeking a highly skilled Principal Systems Engineer to join our client's 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
Bachelor’s degree in Engineering, Computer Science, or related technical field required; Master’s 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. 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. Compensation
$160,000-$190,000 per year
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Maple Grove, MN | Direct Hire | $160,000–$190,000 (Flexible) | Onsite We are seeking a highly skilled Principal Systems Engineer to join our client's 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
Bachelor’s degree in Engineering, Computer Science, or related technical field required; Master’s 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. 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. Compensation
$160,000-$190,000 per year
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