Senior Engineer II - Quality Design & Reliability Assurance

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
• Lead and/or support risk analysis activities (FMEAs and SHAs)
• Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis)
• Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes
• Work knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
• Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations
• Support transfer to manufacturing activities both in product development and base business
• Contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions
• Develop inspection methodology and acceptance criteria for inspection sampling plans
• Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
• Support Design and Technical Review
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
• Show project management and leadership abilities
• Participate to internal and external audits
• Maintain the Quality System Qualifications

Requirements

• Bachelor’s degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical)
• 5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP
• Strong analytical skills and a working knowledge of problem-solving methodologies
• Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
• Excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
• Excellent organizational, verbal and written communication skills
• Proficient with the MS Office Suite, and statistical software
• Must be able to work independently with minimal supervision
• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives

Qualifications

• Passionate about innovation and quality in healthcare
• Ability to work in a fast-paced, dynamic environment
• Self-motivated and proactive
• Strong interpersonal and communication skills
• Ability to work collaboratively with cross-functional teams

Skills

• Experience with ISO11607, 10993, and functional cascading system requirements to component drawings
• Knowledge of Y14.5 and ability to balance its use with business needs
• Experience with risk-based decision making and flexible environments
• Experience with statistical methods and process/design excellence tools
• Experience with DFSS techniques, process Improvement techniques, and Lean process improvement techniques
• Experience with Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
• Experience with conducting and supporting the development of test methods in equipment, process, and product qualifications/validations
• Experience with root cause investigations using various problem-solving techniques and tools
• Experience with developing inspection methodology and acceptance criteria for inspection sampling plans
• Experience with leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
• Experience with fulfilling design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
• Experience with supporting Design and Technical Review
• Experience with communicating effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
• Experience with showing project management and leadership abilities
• Experience with participating to internal and external audits
• Experience with maintaining the Quality System Qualifications

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Pay

Pay Range: $82,000.00 - $113,000.00 USD