Product Support Design Quality Engineer II (US - Mansfield, MA)

Product Support Design Quality Engineer II

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.  

This Product Support Design Quality Engineer II role is located in US - Mansfield, MA supporting Smith + Nephew Joint Repair product lines. This position will support sustaining activities for launched Joint Repair products, such as design change support, product issue support, and Post Market Surveillance data review. They will lead root cause investigations, review Design Verification and Validation documents, and support internal/external audits. This individual must be knowledgeable in Design Controls, Change Control, and Risk Management. This individual is expected to uphold compliance to regulatory requirements and Smith + Nephew Quality standards, policies, and procedures in all job aspects.

What will you be doing?

• 50% - Support sustaining projects (Quality Plans, remediation activities, etc.). Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.

• 30% - Support compliance and complaint management processes (CAPA's, NCR's, Post Market Surveillance activities, Management Review, Risk Management Review, Complaints Investigations). Serve as a quality engineering resource to conduct / approve investigations.

• 20% - Identify/Support continuous improvement activities. Engage with cross functional resources to receive product feedback.

• 10% - Support internal/external audits, when necessary.

What will you need to be successful?

• Bachelor’s degree in engineering or related discipline.

• Minimum 1 year experience.

• Working knowledge of the following standards: ISO 13485:2016, ISO 14971:2019, IEC/ISO 62366:2015.

• Working knowledge in the following regulations: FDA 21CFR820, European MDD, European MDR.

• Proficiency in the following Software Applications: MS Office, MS Excel, MS Powerpoint, Minitab or other statistical software, SAP, and Agile PLM. Experience working across multiple Quality Systems.

• Time management, ability to plan and schedule multiple projects and tasks. Understanding of statistical tools, including, but not limited to: Bayes Success-Run, Weibull Analysis, t-tests, tolerance analysis, capability analysis, design of experiments/ANOVA, etc.

• Experience in CAPA, NCR systems including problem identification, root cause investigation, corrective action/preventative action definition and implementation.

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

• Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  

• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program 

• Flexibility: Hybrid Work Model (For most professional roles)  

• Training: Hands-On, Team-Customized, Mentorship  

• Extra Perks: Discounts on fitness clubs, travel and more!  

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.