Sr. Mechanical Design Engineer

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Sr. Mechanical Design Engineer, Active Implantable Devices is primarily responsible for defining, designing, and developing medical devices and related accessories. Experience with implantable, minimally invasive, or catheter-based medical devices, especially with exposure to one or more implantable lead systems, neuromodulation devices, cardiac rhythm management systems, implantable enclosures, or hermetic packaging is preferred but all qualified and capable driving engineers will be considered. Owns efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. Able to multitask and run multiple projects while meeting customer commitments. Lead the design efforts for small to medium scale programs, independently, acting as a technical lead and mentor to other engineers on these programs.

Key Responsibilities:

• Contribute to the design and development of implantable and interventional medical devices from concept through commercialization.:

• Independently execute mechanical engineering activities for complex medical device systems and subsystems.

• Develop detailed mechanical designs, assemblies, components, fixtures, and prototype hardware.

• Generate engineering documentation including drawings, specifications, test protocols, and reports.

• Support development activities across implantable leads, implantable pulse generators, sensing devices, delivery systems, or related medical technologies.

• Participate in concept generation, design reviews, and technical problem-solving activities.

• Design and refine mechanical components and assemblies using sound engineering principles and design-for-manufacturing practices.

• Perform engineering analyses including:

• Tolerance analysis

• Fatigue considerations

• Mechanism evaluation

• Material selection

• Design tradeoff assessments

• Participate in root cause investigations and corrective action activities

• Analyze test results and implement design improvements based on data-driven decisions.

• Support verification and validation activities including:

• Mechanical bench testing

• Simulated use testing

• Environmental conditioning

• Fatigue testing

• Dimensional evaluation

• Reliability assessments

• Work collaboratively with cross functional teammates including systems, electrical, software, manufacturing, and quality engineering by:

• Supporting integration of mechanical designs with broader system requirements.

• Participating in design reviews, technical discussions, and project planning activities.

• Communicating technical progress, risks, and recommendations to project teams and management.

• Manage workload to support various projects, in small to medium scale and complexity

• Mentorship of junior engineers in various functions within your areas of expertise

• Maintain compliance to procedures and regulatory requirements

• Provides regular status updates to management and or customer

• Writes/updates work instructions, part specifications, verification protocols, and various technical documents

• Reliable, consistent, and punctual attendance is an essential function of the job

• Complies with company, quality, and safety standards, policies, and procedures.

• Other duties as assigned.

Must Have:

• A Bachelor's degree in a STEM engineering discipline
• 5 years of experience required in Design Engineering
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
• Proficiency with Solidworks required
• Knowledge of dimensioning and tolerances, GD&T
• Computer skills associated with Microsoft software
• Must be able to read, write and speak fluent English
• Excellent reading, writing, communication, and organizational skills
• Maintains performance with changing priorities under supervision
• Possess team collaboration skills
• Strong mechanical aptitude

Salary Range: 110,000 to 130,000 based on skills and experience

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.