Senior Product Development engineer

Job 2545 - Catheter Design Engineer - project located near Saint Paul, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative and corrective action and create a roadmap for ongoing future improvement by identifying, integrating and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

100% On site

• Execution of all areas of engineering and manufacturing to ensure company goals are met or exceeded.
• Perform design engineering tasks on new device technologies, including concept, development, design, prototyping, design‑for‑manufacture, and working with project teams to execute deliverables and company goals.

• Advanced knowledge of catheter/delivery system design concepts, materials and processing.
• Experience with catheter device manufacturing processes and equipment.
• Experience with design verification and validation of devices.
• Experience with operating projects under ISO design controls.
• Understanding of medical device regulations and standards.
• Excellent collaboration and teamwork skills.
• Excellent technical writing skills.
• Excellent problem‑solving, decision‑making and organizational skills.
• Proficiency in Solid Works.
• Proficiency in Microsoft Office.
• Knowledgeable of ERP systems.

• Bachelor’s degree in engineering.
• Minimum of 5 years’ work experience.
• At least 3 years’ experience working in a medical device quality system (ISO 13485 or FDA QSRs).

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

Sponsorship is not available for this position.

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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.