Principal R&D Engineer

Principal Mechanical Engineer
Golden Valley MN Direct-Hire $120000 $145000 (Flexible) 100% Onsite

Konik is partnering with a leading manufacturer of disposable medical devices to add a Senior Mechanical Engineer to their R&D team. This role focuses on sustaining engineering leading design change programs and ensuring product improvements meet strict regulatory quality and manufacturing standards. The ideal candidate will bring deep expertise in medical device design plastics processing and regulatory compliance while guiding cross-functional teams in executing complex engineering projects.

Senior Mechanical Engineer Responsibilities

• Lead the design and development of product changes for disposable medical devices within sustaining engineering.
• Manage project schedules and budgets while delivering design change programs with minimal supervision.
• Serve as technical expert for supplier materials labeling CAPA/NCR cost reduction and remediation initiatives.
• Investigate and resolve complex engineering challenges using risk-based customer-focused approaches and engineering tools (DFMEA Human Factors Engineering statistical analysis CAD).
• Create maintain and ensure compliance of design history files in alignment with FDA and ISO standards.
• Coordinate and communicate with R&D and global cross-functional stakeholders throughout the product lifecycle.
• Provide mentorship and technical guidance to engineers and technicians as needed.
• Contribute to the companys intellectual property via invention disclosures and patent submissions.

Senior Mechanical Engineer Qualifications

• Bachelors degree in Mechanical Plastics Biomedical Engineering or a related field; Masters preferred.
• 5 years of experience in Class II or Class III disposable medical product development.
• Advanced knowledge of plastics materials and processing (injection molding extrusion ultrasonic welding UV/solvent bonding sterilization).
• Strong understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Proficiency with CAD design software (SolidWorks Creo) and PDM systems.
• Knowledge of ANSI/AAMI/ISO 14971 standards for medical device risk management.
• Strong problem-solving communication and leadership skills; ability to train and mentor team members.
• Demonstrated ability to implement best practices innovation and continuous improvement initiatives.
• Willingness to work in a flexible workplace environment with a minimum of 3 days onsite per week.

Benefits

• Competitive base salary with potential performance-based incentives.
• Comprehensive medical dental and vision coverage.
• 401(k) with employer match.
• Paid time off and company holidays.
• Professional development and training opportunities.

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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.

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