Sr. Mechanical Engineer

Our location in Sylmar, CA currently has an opportunity for a Sr. Mechanical Engineer in our Cardiac Rhythm Technologies division.

What You’ll Do

Design medical devices to meet user needs.

Establish requirements and specifications for the devices (including justification and supportive testing).

Use experimental, empirical and numerical analysis to evaluate designs. Lead test method and model development. Create and own mechanical design drawings and models.

Identify and mitigate project risks.

Work with internal departments and external vendors to obtain prototype parts and to expand vendor capabilities.

Lead pre‑clinical and support clinical testing of devices.

Lead design reviews and support physician visits.

Maintain a detailed understanding of the developing clinical environment and evolving clinical needs.

Maintain a detailed understanding of division, FDA and ISO regulation and provide input into shaping division quality and regulatory requirements.

Work with project management to develop overall schedule and manage time and tasks within schedule.

Make decisions on material usage including implant‑grade metals and polymers.

Work closely with outside vendors and manage complex projects with them.

Document and run design verification and validation testing to be submitted to the FDA and other regulatory bodies.

Support company initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.

Comply with U.S. Food and Drug Administration (FDA) regulations, Company policies, operating procedures and task assignments.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Mentor junior engineering team members providing engineering and technical leadership.

Required

Bachelor’s Degree in Mechanical Engineering or related field, or an equivalent combination of education and work experience.

Minimum 5 years of experience designing and testing medical devices.

Experience with a variety of manufacturing processes and designing for manufacturability.

Ability to lead small teams and work within large multidisciplinary teams as an individual contributor in a fast‑paced, changing environment.

Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.

Ability to multitask, prioritize and meet deadlines in a timely manner.

Exposure to latest design tools and techniques (Six Sigma, DFM, analytical design).

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to leverage and/or engage others to accomplish projects.

Preferred

Master’s Degree in Mechanical Engineering or related field.

Class III medical device R&D experience.

Cross‑functional team experience.

Experience designing and testing electromechanical medical devices.

Proficiency in medical device design controls, CAPA, production and process controls, and risk management.

Wide variety of manufacturing processes and DFM experience.

SolidWorks/Creo or other CAD experience.

Experience with Analytical design, Design for Six Sigma, or similar tool sets.

What We Offer

Training and career development, including onboarding programs for new employees and tuition assistance.

Competitive compensation, incentives and retirement plans for financial security.

Health care and well‑being programs including medical, dental, vision, wellness and occupational health.

Paid time off.

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

The stability of a company with a strong financial performance and community involvement.

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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