Advanced Medical Device Design Quality Assurance Expert

1 week ago

Plano, Texas, United States Abbott Full time

Abbott, a global healthcare leader, empowers individuals to live life to the fullest. With a diverse portfolio of life-changing technologies across diagnostics, medical devices, nutritionals, and pharmaceuticals, we strive for excellence in serving people worldwide.

Join us at Abbott

At Abbott, you'll embark on a journey where your skills grow, you learn, and care for yourself and loved ones. Enjoy:

  • A dynamic environment with opportunities to build a career that thrives globally.
  • Comprehensive medical coverage via the Health Investment Plan (HIP) PPO, ensuring your well-being is our priority.
  • An exceptional retirement savings plan with substantial employer contributions.
  • Tuition reimbursement, student debt programs like Freedom 2 Save, and FreeU education benefits – invest in your future without breaking the bank.
  • Collaborate with an internationally recognized company named among Fortune's most admired companies worldwide.
  • Pursue a career with a brand known as one of the best places to work, valued by employees, customers, contractors, and vendors alike.

The Opportunity

This role is based at our Plano, TX site within the Neuromodulation division.

We develop innovative implantable devices compatible with mobile technology to help those suffering from chronic pain and movement disorders. Our non-opioid therapies provide interventional pain therapy throughout the pain continuum.

As a Senior Design Quality Engineer, you will ensure new or modified products conform to quality standards, establishing compliance with our quality system. You will maintain strong partnerships with cross-functional teams, promoting organizational success while safeguarding patient/user safety and meeting business needs.

Your Key Responsibilities

  • Serve on product development teams to promote quality in projects, ensuring timely completion of design control deliverables.
  • Execute and support various aspects of design control processes, such as design input requirements, design outputs, design verification, and design validation.
  • Assess and establish customer and product requirements, supporting product development equipment qualification activities and inspection method development.
  • Account for applicable standards documents, labeling verification planning, essential output reports, and general safety and performance requirements.
  • Maintain risk management deliverables, ensuring continued acceptability of products based on post-market feedback.
  • Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Develop positive and cooperative communications with all levels of employees, customers, contractors, and vendors.

Required Skills and Qualifications

  • Bachelor's degree in Engineering or Technical field, or equivalent combination of education and experience.
  • 5+ years of quality engineering experience and demonstrated use of quality tools/methodologies.
  • Excellent verbal, written, and interpersonal communication skills.
  • Strong analytical/problem-solving, negotiation, and presentation skills.
  • Prioritize and meet deadlines in a timely manner.
  • Advanced computer skills, including statistical/data analysis and report writing.

Benefits

  • Competitive salary: $83,000 - $166,000 per year.
  • Free HIP PPO medical plan for participants who complete a wellness assessment.
  • Exceptional retirement savings plan with high employer contribution.
  • Tuition reimbursement and student debt programs.
  • FreeU education benefits.
  • International recognition as a great place to work.

About Abbott

Abbot is an Equal Opportunity Employer committed to employee diversity. We welcome talented individuals from around the world to join our team and shape the future of healthcare together.

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