Risk Management Engineer II

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career developmentwith an international company where you can build the career youve dreamed of.

• Free medical coveragefor employees who qualify under our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings planwith a high employer contribution.

• Tuition reimbursement theFreedom 2 Savestudent debt program and theFreeUeducation benefitan affordable and convenient path to earning a bachelors degree.

• A company recognized as agreat place to workin dozens of countries worldwide and named one of themost admired companies in the worldbyFortune.

• A company honored as one of thebest big companies to work for as well as thebest place to work for diversityworking mothersfemale executives andscientists.

The Opportunity

This position is based in ourPlymouth MNlocation within theElectrophysiology Medical Device Abbotts Electrophysiology (EP) business were advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillationhelping people restore their health and get on with their lives.

TheStaff Risk Management Engineerensures new products perform their intended functions safely and comply with our quality system. This role collaborates with clinical design engineering regulatory labeling and post-market surveillance teams to ensure risks are appropriately mitigated evaluated disclosed and monitored. The engineer maintains strong cross-functional partnerships to protect patient and user safety while meeting business needs.

What Youll Work On

• Product Development Support/Execute Risk Management Plan

  • Support system/product risk management planning

  • Assist in requirements development to ensure quality and linkage to the risk management file

  • Support system hazard analysis and risk assessments (FTAs FMEAs)

  • Analyze and incorporate legacy inputs; coordinate cybersecurity risks with patient safety implications

  • Ensure traceability among hazards risks analyses evaluations controls and verification of control effectiveness

  • Contribute to system/product risk management reports

• Post-Market Surveillance

  • Serve as the point of contact for tracking and responding to post-market signals (event-based and periodic)

  • Lead updates to the risk management file including annual updates

  • Conduct complaint analysis and develop action plans

  • Provide backroom support for audits

• Risk Management Tool Mastery

  • Develop proficiency in primary risk assessment tools (e.g. FMEA FTA)

• Process Excellence

  • Identify and support improvements to risk management processes and infrastructure

  • Support changes driven by external regulations standards guidance or internal Abbott Quality Policies

  • Assist with CAPA efforts linked to risk management

Required Qualifications

• Bachelors degree in Engineering or a technical field

• 3 years of experience

• Previous design quality engineering experience and demonstrated use of quality tools/methodologies

• Experience working in a cross-division or enterprise-wide business model

Preferred Qualifications

• Advanced degree

• Prior medical device experience

• Experience in a cross-division or enterprise-wide business model

• Working knowledge of FDA GMP and ISO 13485

• Familiarity with standards such as ISO 14971 IEC 60601 IEC 62304 IEC 62366 ISO 10993 and/or ISO 14155

• Systems or clinical engineering experience

• Experience with basic statistics and/or reliability methodologies

• Experience facilitating risk assessments (e.g. FMEAs or FTAs)

What We Offer

At Abbott you can have a good job that grows into a great career. We offer:

• A fast-paced work environment where your safety is a priority

• Clean well-lit and temperature-controlled production areas

• Training and career development including onboarding programs and tuition assistance

• Financial security through competitive compensation incentives and retirement plans

• Health care and wellness programs including medical dental vision and occupational health

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a strong financial track record and deep community involvement

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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