Principle Mechanical Engineer
Hopkins, MN | Direct-hire | $110,000-$130,000 | Hybrid
Konik is partnering with a local medical device company that is looking to add a Principle Mechanical Engineer to their growing team. The individual in this position will play a major role in equipment design, module fabrication, maintenance strategies, data management, regulatory compliance, and risk assessments.
Principle Mechanical Engineer Responsibilities:
- Collaborate across departments (including sales and R&D) throughout the development lifecycle, participating in design reviews and product evaluations.
- Oversee the product development process from initial concept to market, ensuring the delivery of safe, effective, and reliable solutions.
- Partner with the core leadership team to develop innovation strategies, set product development priorities, and create execution roadmaps.
- Drive aggressive but attainable timelines for new technology or product rollouts.
- Spearhead the development and refinement of fabrication techniques, introducing new processes or upgrading current equipment to align with next-gen product goals.
- Achieve ambitious cost, performance, and production targets.
- Work closely with technicians to conduct QA/QC testing on products and materials, ensuring the highest standards of quality.
- Analyze testing results, generate detailed documentation for fabrication protocols, and report on production quality to support design control records.
- Mentor and guide junior engineers, fostering a collaborative and growth-oriented work environment.
- Lead strategic decision-making related to R&D and product development.
- Drive new product innovation, design for manufacturability, and equipment upgrades to meet customer needs for next-generation solutions.
- Collaborate with Supplier Quality Engineers and engage with customers to meet audit and compliance requirements.
- Act as a trusted advisor and thought leader across various functions.
- Maintain and support existing product lines, ensuring continued quality and efficiency.
Principle Mechanical Engineer Requirements:
- Bachelor's degree in Mechanical Engineering or a related field, or equivalent work experience aligned with the responsibilities of the role.
- Experience within the medical device industry, particularly in respiratory or cardiac support devices, with a preference for those experienced in blood-contacting medical technologies.
- Proven success in driving innovation, leading product development projects, and overcoming fabrication or process challenges.
- Familiarity with working under medical device Quality Systems, including design controls compliant with 21CFR820.30.
- Strong experience in risk management activities, including conducting design and process FMEAs.
- Exceptional communication skills, with the ability to collaborate effectively within a team-based environment.
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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.