Sr Engineer, NPI and Lifecycle Quality

Johnson & Johnson • Irvine, CA

8d • Onsite

About The Position

The Sr Engineer, NPI and Lifecycle Quality provides quality and technical leadership to ensure new and existing medical devices meet their intended use. This role involves quality leadership on product project teams, ensuring Critical to Quality (CTQs) attributes are established, implemented, and met. It also includes ensuring effective risk management for product harms and hazards, improving process capabilities, and leading the development team in design control strategy and implementation. The position requires collaboration with functional business partners to address quality issues during new product development, design changes, and product verification/validation. Key activities also include leading risk management and human factors efforts, such as identifying high-risk areas, establishing and monitoring mitigation plans, and ensuring management awareness and support for risk mitigation efforts. Support for Quality Management Systems, including Design Control, Risk Management, Change Control, Non-Conformance and Corrective Actions, and Audits, is also a core responsibility.

Requirements

• Bachelors or equivalent university degree in Engineering or other related technical field is required.
• 2-4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry.
• Strong communication, interpersonal and organizational skills.
• Practical understanding of QSR/ISO medical device regulations especially design controls, and risk management.
• Ability to function in a team environment and deliver on team objectives.
• Strong attention to detail.
• Strong written and verbal communication skills.
• Developed presentation skills.

Nice To Haves

• Experience in Medical Device industry.
• Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices
• Human Factors Engineering experience.

Responsibilities

• Quality leadership on product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
• Ensures effective risk management or product harms and hazards and improves capability of processes.
• Leads development team in design control strategy and implementation
• Collaborates with functional business partners to proactively address quality issues during new product development, design changes and product verification/validation.
• Leads activities associated with risk management and human factors. This includes working with engineers and product development to identify areas of high risk within their processes; establishing, monitoring and implementing risk mitigation plans; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
• Quality Management Systems support including Design Control, Risk Management, Change Control, Non-Conformance and Corrective Actions and Audits.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior