Sr Eng RD Soft Eng
About The Position
The Senior Quality Engineer, Product Software Development provides quality leadership to new product project teams developing medical device software systems, including Software as a Medical Device (SaMD). The role serves as a subject matter expert in requirements gathering, software risk assessments, test strategy, design controls, and defect analysis. It supports software design, development, and testing, as well as regulatory submissions, audits, supplier oversight, and compliance with applicable medical-device standards and regulations. The position works with R&D and cross-functional teams to refine requirements, review architecture and design documentation, track verification activities, review test results, manage defects, and create software risk documents. It also owns or supports audit findings, non-conformances, CAPAs, and root-cause investigations; provides training and mentorship; and helps protect patient ePHI and PII. The position reports to a Manager or Senior Manager of Quality Engineering and may be based in West Chester, Pennsylvania; Warsaw, Indiana; Raynham, Massachusetts; Palm Beach Gardens, Florida; or Rheinsheim, Germany.
Requirements
- Bachelor’s degree or university degree required.
- At least 4 years of regulated-industry experience in quality, new product development, or manufacturing engineering required.
- Ability to apply appropriate quality tools, systems, and processes to meet departmental goals and objectives.
- Demonstrated ability to prioritize and manage multiple projects while meeting deadlines and budgets.
- Ability to perform duties in accordance with policies and procedures and comply with civil rights requirements.
- Ability to work in a team and demonstrate good interpersonal, organizational, verbal, and written communication skills.
- Extensive use of a personal computer and associated tools, including Word, Excel, and PowerPoint, required.
- Medical device industry experience.
Nice To Haves
- Advanced degree preferred.
- Degree in Engineering, Computer Science, Information Systems, Biomedical Engineering, or Bioengineering preferred.
- ASQ Certification as a Software Quality Engineer, or equivalent, preferred.
- Skills listed in the posting include Agility Jumps, Analytical Reasoning, Coaching, Collaboration, Critical Thinking, Model-Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), and Technologically Savvy.
Responsibilities
- Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products.
- Provide leadership, guidance, and expertise on software development processes, procedures, and practices.
- Partner with R&D to refine requirements and ensure architecture and design documents are comprehensive.
- Facilitate documentation and tracking of verification activities, including code review findings.
- Review test-case execution results and manage defects.
- Facilitate software risk assessment sessions and own development of risk documents.
- Support regulatory filings and registrations.
- Support internal and external audits or inspections of SaMD products and processes; own non-conformances or CAPAs and drive root-cause investigations.
- Provide technical support for audits of software suppliers and software consultants.
- Conduct training on medical device software development processes and quality systems.
- Train and mentor new engineers and lower-level quality engineers.
- Provide expertise in applicable industry standards and regulations, including IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, and HIPAA.
- Guide project teams, suppliers, and other disciplines to ensure compliance with company policies, procedures, and medical device regulations.
- Ensure that patient ePHI and PII data is protected and security requirements are met.
- Comply with applicable laws, regulations, company policies, Health Care Compliance Program requirements, and Code of Conduct requirements relating to DePuy Synthes business activities.
- Communicate business-related issues or opportunities to the next management level.
- Follow applicable company Health, Safety, and Environmental guidelines and ensure compliance with applicable federal, state, local, and company requirements.
- Perform other duties as assigned.
- Collaborate with Quality, R&D, Product Owners, Program Management, other product teams, and supporting teams on product issues, requirements, schedules, and design history file documentation.
Benefits
- Retirement plan (pension), subject to plan terms.
- 401(k) savings plan, subject to plan terms.
- Eligibility to participate in the long-term incentive program.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year, with stated higher allowances for employees residing in Colorado or Washington.
- Holiday pay, including floating holidays: 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Parental leave: 480 hours within one year of the birth, adoption, or foster care of a child.
- Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver leave: 80 hours in a 52-week rolling period.
- Volunteer leave: 32 hours per calendar year.
- Military spouse time off: 80 hours per calendar year.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
