Senior Design Quality Engineer

Senior Design Quality Engineer – Danvers, MA

Location:

Danvers, Massachusetts, United States of America

Job Function:
Quality – R&D/Scientific Quality

We are searching for a Senior Design Quality Engineer to join our Med Tech team in Danvers, MA. This role supports new product development and sustaining activities, and plays a key part in product risk management, cybersecurity, change controls, and design controls.

• Provide Design Quality Engineering support throughout the product development lifecycle, ensuring compliance with regulations and internal Quality Management System procedures.
• Support new product development and sustaining engineering projects, including review and approval of change orders.
• Use technical expertise to rapidly innovate medical devices for chronic heart failure patients.
• Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Design Failure Modes and Effects Analysis, and Risk Management Reports.
• Participate in reviewing design inputs and outputs, ensuring risk control measures and cybersecurity requirements are translated into product requirements.
• Participate in V&V activities: review verification and validation plans, test protocol reports.
• Participate in product cybersecurity activities including security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
• Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Contribute to the Quality System performance measures by completing tasks on time with a high level of quality.
• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
• Support 3rd party audits, including follow‑up on actions and quality department initiatives.
• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Education: Minimum bachelor’s degree in engineering or scientific discipline; advanced degree in a related field is an asset.

• Minimum 6 years of work experience in a highly regulated industry, or equivalent to a master’s degree in engineering or scientific discipline; medical device and/or biotechnology industry preferred.
• Experience and knowledge of quality system regulations, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP, and/or MDD/MDR.
• Experience conducting and furnishing RMF and Design Failure Mode Effects and Analysis.
• Demonstrated experience in design control and risk management activities.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and internationally.

• Work experience in electro‑mechanical devices.
• Familiar and working experience with CI tools, reliability and statistical sample size.

• Position requires working onsite in Danvers, MA for a minimum of 3 days per week and requires 10% domestic and/or international travel.

$ – $

• Vacation: 120 hours per calendar year
• Sick Time: 40 hours per calendar year (48 hours if resident in Colorado, 56 hours if resident in 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/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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via  Internal employees contact AskGS to be directed to your accommodation resource.