Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our 109,000 colleagues serve people in more than 160 countries.
About Abbott For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive.
Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.
Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents Our location in Westford, MA , currently has an opportunity for an Senior Staff Quality Engineer
– Quality Hardware WHAT YOU’LL DO: Lead product development core team members responsible for producing quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development.
Act as technical and regulatory subject matter expert on imaging hardware systems and related software with strong knowledge of requirements and applicability of IEC 60601 and 62304 standards Consistently, and on an ongoing basis, develop and apply advanced theories, methods, and research techniques to the investigation and solution of complex technical problems.
Responsible for implementing and maintaining the effectiveness of the quality system.
Analyze, evaluate, and plan methods of approach to and organize a means to achieve the solution of complex technical problems.
Conduct investigations of considerable complexity pertaining to the development of new designs, methods, materials, or processes, and investigate possible applications of the results.
Provide technical consultation to technical staff.
Apply the results of reviews of literature and current practices relevant to the business; use results to determine strategic technical direction.
Support internal and external regulatory audits as a technical subject matter expert.
Provide regulatory responses and submissions Establish and define the theoretical bases and principles which should apply, the empirical test procedures to be used, and the estimated time, expense, and manpower for completion.
Review project progress and evaluate results.
Review, generate, and approve related inputs such as FMEAs and specifications.
Evaluate vendor capabilities to provide required products or services.
Specify equipment, materials, and supplies required for the completion and implementation of technical projects.
Plan and direct major technical phases of projects within a specific area.
Provide technical direction to and coordinate the efforts of engineers and technical support staff in the performance of assigned projects.
Provide input to the manager on staffing decisions and future strategies and goals.
Lead or enable project completion.
Interface with product team members, manufacturing quality and medical affairs, Development managers, operations and business unit managers.
Communicate with outside decision makers in a manner appropriate to the goals of the communication EDUCATION AND EXPERIENCE YOU’LL BRING: REQUIRED Minimum 6 years work related experience Bachelor level degree in an Engineering Discipline Medical Device Hardware design background Working understanding of FDA, GMP, and ISO 13485 Working understanding of IEC 60601 Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization Ability to leverage and/or engage others to accomplish projects PREFERRED Bachelor’s Degree in Electrical, Mechanical, or Biomedical Engineering Advanced Degree 10 years work related experience Working understanding of IEC 62304 WHAT WE OFFER : At Abbott, you can have a good job that can grow into a great career.
We offer: A fast-paced work environment where your safety is our priority Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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