Principal R&D Engineer

The Principal R&D Engineer, Mechanical will act as technical lead for cross-functional product development teams executing new product and line extension projects..  This position will interact with Coloplast personnel, external physicians, and external contract manufacturers and suppliers, throughout the entire development cycle. 

 

Major Areas of Accountability:

• Perform original and iterative design for Interventional Urology implantable and active implantable devices.
• Lead a team through the design control process and procedures, including customer requirement generation, design inputs and outputs, and verification.
• Complete relevant tasks to fulfill major program milestones by partnering with Project Management to ensure activities are planned out for the technical team.
• Create and maintain all necessary documentation throughout the development cycle for assigned projects.
• Assure risk mitigation through robust design and detailed product requirements.
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other duties as assigned

 

Essential Qualifications:

• Bachelor’s Degree in Mechanical Engineering or Bio-Medical with a focus on Mechanical Engineering
• 7+ years related experience and/or training; or equivalent combination of education and experience – Class III medical device experience
• Understanding of advanced engineering concepts and principles.
• Experience with device assembly, tolerancing, and possess basic drafting skills
• Good understanding of materials as they relate to medical devices.
• Able to develop test protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge.
• Familiarity with FDA, ISO and EN Standards as they apply to medical devices.
• Ability to travel up to 10%

 

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.

• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.

• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.

• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.

• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.

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