Principal Mechanical Engineer 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 company's intellectual property via invention disclosures and patent submissions. Senior Mechanical Engineer Qualifications Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or a related field; Master's 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.
