Senior Design Assurance Engineer

Coloplast; Minneapolis (MN); Hybrid; USD 106,000 - 159,000; Full time

Benefits offered by this job

Health and wellness benefits

401(k) with match

Flexible work arrangements

Job summary

Coloplast is seeking an Interventional Urology Senior Design Assurance Engineer to support new product development and commercial products. The role involves leading design reviews, defining design inputs/outputs, and ensuring compliance with design controls and regulatory expectations.

You will collaborate with R&D, conduct risk analyses, support verification/validation, and drive quality-system deliverables to improve efficiency. Travel up to 10% may be required.

Qualifications

• BS in Engineering with Biomedical or Mechanical preferred.
• ASQ Certified Quality Engineer preferred.
• Ability to work independently and with general direction.
• Familiarity with design controls, risk management, statistics, and test method validation.

Responsibilities

• Lead and participate in design reviews for new product development and commercial products.
• Collaborate with R&D to define design inputs/outputs and relationships.
• Apply design standards, create and validate test methods.
• Document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Support design verification, validation, and usability testing.

Skills

Independent work

Task management

Team leadership

Technical writing

Design controls

Risk management

FDA/QSR/ISO knowledge

Problem solving

Travel readiness

Education

BS in Engineering

ASQ CQE

Job description

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The Interventional Urology Senior Design Assurance Engineer is responsible for supporting new product development and commercial products.

Major Areas of Accountability

• Participate in New Product Development Phase Reviews; lead/participate in Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Ensure relevant design standards are appropriately applied and satisfied. Create and support the development and validation of new test methods.
• Determine and document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Support the execution of design verification and validation, as well as usability.
• Generate/support test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing, including shelf life and stability.
• Drive improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Support regulatory approvals and responses to regulatory questions.
• Manage the stability test program
• Support and execute design and process changes to commercialized product.
• Support the transfer of new product development projects from development to production.
• Support internal and external audits.
• Manage statistical support for test method validations, sample size requirements, etc.
• Interacts with external contract manufacturers and suppliers
• Provide technical support based on overall project plans with the development of products in compliance with design controls, international standards, and FDA or other regulatory body guidelines.
• Manage product stability program to ensure all products have adequate heat-age and real-time aging for support of shelf life.
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other job duties as assigned

Basic Qualifications

• BS in Engineering (Biomedical or Mechanical preferred)
• 5+ years related experience and/or training
• ASQ Certified Quality Engineer preferred
• Ability to work independently and with general direction.
• Ability to define, organize, and manage individual and team based tasks.
• Provide direction to extended team members.
• Good written and verbal communication, with strong technical writing skills.
• Understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Knowledge and application of FDA, QSR, ISO 13485 and ISO 14971 requirements.
• Structured and methodical problem-solving approach.
• Ability to travel up to 10%.
• Personifies and fosters the Coloplast Mission, Vision and Values.

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.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The compensation range for this position is $105,868 - $ $158,802. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world ´ s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

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.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark