Senior Mechanical Engineer - Sustaining

Position Summary:

The Senior Sustaining Mechanical Engineer will play a key role in the support, improvement, and lifecycle management of existing electromechanical medical devices and their sterile disposable counterparts. This role involves analyzing, modifying, and enhancing current designs to improve performance, reliability, manufacturability, and compliance with evolving regulatory requirements. Responsibilities include leading and executing design modifications, failure analysis, root cause investigations, and product enhancements. This involves requirements assessment, engineering modeling and analysis, development of test methods and fixtures, and collaboration with suppliers to ensure high-quality, cost-effective solutions. Significant creativity and experience are essential for applying engineering principles to analyzing and verifying components (machined, sheet metal, injection molded, extruded, etc.), assemblies, mechanisms, and systems. The Senior Sustaining Mechanical Engineer must be a self-starter capable of driving continuous improvement initiatives, addressing field and production issues, and collaborating with cross-functional teams to maintain and optimize product performance throughout its lifecycle.

Primary Duties and Responsibilities:

• Support and improve capital medical equipment and sterile disposables by designing, developing, modifying, and testing mechanical components.
• Ensure reliability, manufacturability, serviceability, and compliance while maintaining design quality.
• Diagnose and resolve mechanical system failures, implementing design modifications as needed.
• Specify, qualify, and document new mechanical design updates using appropriate materials and manufacturing processes.
• Conduct design verification and validation testing for electromechanical medical devices and disposables.
• Create and manage engineering documentation, including design specifications, test plans, CAD models, and change orders.
• Interface with Operations and Manufacturing teams to ensure smooth product transitions and support production troubleshooting.
• Drive continuous improvement initiatives for quality, reliability, and cost optimization of existing products.
• Ensure compliance with regulatory and quality standards (FDA, UL, REACH/RoHS, MDD/MDR).
• Work with cross-functional teams to evaluate design constraints, trade-offs, and project deliverables.
• Manage multiple projects, track milestones, and maintain effective communication with stakeholders.
• Collaborate with vendors and contract manufacturers to ensure compliance with product specifications and quality standards.

Qualifications (Knowledge, Skills & Abilities):

Minimum

• B.S. in Mechanical or Biomedical Engineering
• 5+ years of experience developing electromechanical devices in the medical device space or similar regulated industry
• Working knowledge of finite element analysis, tolerance analysis, and geometric tolerances.
• Proven project management skills
• Strong problem-solving and critical thinking skills
• Effective communication skills, both oral and written, with strong organizational skills and attention to detail
• Strong leadership abilities to influence and empower others
• Self-starter with strong initiative and personal accountability
• Desire to mentor and coach technical team members
• Proficient in SolidWorks, including drawing creation
• Working knowledge of finite element analysis, tolerance analysis, and geometric tolerances.
• Design of injection molded, extruded, machined, formed, sheet metal and other metal/plastic components
• Working knowledge of statistics: design of experiments, data analysis, statistical methods and presentation of results

Preferred:

• 3+ years medical device experience
• Experience leading teams or working cross-functionally in an engineering environment
• Knowledge of common sterilization processes (gamma, E-beam, EtO, etc)
• Knowledge of common bonding and manufacturing processes such as solvents, UV adhesive, RF welding, etc.
• Familiar with use of 3D printing and design
• Familiar with cath lab procedures used in diagnostic and interventional cardiac imaging as well as peripheral imaging, TAVR procedures, neuro imaging, and CT/MR imaging.

Compensation & Total Rewards:

Estimated Starting Salary Range: $115,000 - $125,000

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards:

• Paid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
• Choose - You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.