Design Quality Engineer II

Johnson & Johnson Innovative Medicine • Danvers, MA

1d • $92,000 - $148,350 • Hybrid

About The Position

We are searching for the best talent for Design Quality Engineer II role to join our MedTech Quality organization located in Danvers, MA. The ideal candidate for the Quality Engineer position will lead various New Product Development activities as well as play a role in product risk management, manufacturing qualifications, and design controls. This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed. Come join our Abiomed team today!

Requirements

• A minimum of a Bachelor's degree in an engineering or scientific discipline is required.
• Must have in depth knowledge of and ability to apply quality system regulation, including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR and others.
• 2+ years of work experience in a highly regulated industry is required or equivalent masters degree in engineering or scientific discipline.

Nice To Haves

• An advanced degree in a related field is also an asset.
• Medical Device and/or Pharmaceutical industry is preferred.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
• Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
• Design control or new product development is preferred.
• Experience supporting or conducting Process Verification / Validation activities is preferred.
• Experience with Blueprint reading/literacy including GD&T is preferred.
• Familiarity with inspection methods and techniques is an asset.

Responsibilities

• Support New Product Development projects for our Impella product portfolio, emphasizing on Risk Management.
• Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients.
• Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation.
• Develop and/or review test protocols, reports, and engineering summaries
• Perform process development studies in collaboration with MFG teammates and bring an open mind to design solutions which enable manufacturability internally and at external suppliers.
• Test, and analyze engineering prototypes using statistical analysis in Minitab and apply to the design effort (Multivar chart, t-tests, confidence/reliably analysis, Gauge R&R) to iterate concepts toward extremely innovative yet robust solutions.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Contribute to the success of the Quality System performance measures by completing tasks on time and 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.
• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

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: Mid Level