Senior Design Assurance Engineer, SoftwareColoplast • Minneapolis, Minnesota, United States
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Senior Design Assurance Engineer, Software
Coloplast
- Minneapolis, Minnesota, United States
- Minneapolis, Minnesota, United States
Über
Job Family: Quality Assurance
Country/Region: United States
Major Areas of Accountability
Serve as a Design Assurance partner on New Product Development (NPD) projects, participating in and leading phase, design, and test readiness reviews.
Partner with R&D to define, review, and approve software and system design inputs, outputs, and traceability in compliance with design controls.
Ensure applicable software, electrical, and system standards are correctly applied; support development and validation of software-related test methods.
Lead and support software risk management activities, including Hazard Analysis, Software FMEA, DFMEA, and usability risk assessments.
Support planning and execution of software verification and validation (V&V), including protocol development, test execution oversight, issue investigation, data analysis, and reporting.
Drive continuous improvement of Design Assurance processes, SOPs, and quality deliverables to improve efficiency and compliance.
Act as Design Assurance support for regulatory submissions, responses, and audits (internal and external).
Support design and process changes for commercialized products, including change impact assessment and documentation updates.
Support design transfer from development to manufacturing, including supplier and contract manufacturer interactions.
Provide statistical and analytical support for software test methods, validation strategies, and sample size rationale.
Demonstrate commitment to Coloplast Mission, Values, and Vision.
Other duties as assigned.
Basic Qualifications
Bachelor’s Degree in Computer Science, Computer Engineering, Electrical Engineering, or related field.
5+ years related experience in this field – Medical device experience preferred.
Experience with regulatory standards including IEC 62304, IEC 60601, FDA 510(k), ISO 14971, ISO 13485.
Knowledge of cybersecurity best practices and standards.
Good written and verbal communication.
Ability to consistently work, manage and lead with ethical integrity.
Benefits
Health and Wellness: Comprehensive medical, dental, and vision insurance plans, company-sponsored wellness programs, and mental health resources.
Financial Security: Competitive 401(k) plan with company match that vests immediately, financial planning services, and corporate discount programs.
Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options.
Professional Development: Opportunities for continuous learning, career advancement through training programs, mentorship, and tuition reimbursement.
Recognition and Rewards: Recognition programs, bonuses, awards, and special events.
Community and Culture: Supportive work environment, team-building activities, volunteer opportunities, and sustainability initiatives.
Competitive Compensation: Base salary range $105,868 – $158,802, with potential additional bonuses or incentives.
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.
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Sprachkenntnisse
- English
Hinweis für Nutzer
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