Mechanical Design Engineer II

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 Mechanical Design Engineer II is primarily responsible for defining, designing, and developing

medical devices and related accessories. This position owns efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. The ideal candidate will be able to multitask and run multiple projects while meeting customer commitments.

Key Responsibilities:

• Own the design and development of medical devices through:

• Transformation of internal and external inputs into outputs

• Developing design requirements and specifications with mechanical and electrical components and assemblies

• Creating test methods and corresponding test method validations

• Coordinating design verification activities

• Generating 3D models and engineering drawings utilizing SolidWorks

• Performing tolerance analyses to ensure component interactions are understood

• Understanding the functional performance of the products as they are developed

• Communicating technical risks as they arise

• Host design reviews with internal and external stakeholders

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

• Maintain compliance to procedures and regulatory requirements

• Provide regular status updates to management and or customer

• Write/update work instructions, part specifications, verification protocols, and various technical documents

This is not a remote position.

Must Have:

• A Bachelors degree (STEM engineering discipline preferred) and 2+ years of experience
• Experience in an engineering environment with mechanical, tool design, and manufacturing
• processes (medical device strongly preferred)
• FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
• Proficiency with SolidWorks
• Knowledge of dimensioning and tolerances, GD&T
• Computer skills associated with Microsoft software
• Must be able to read, write and speak fluent English
• Maintain performance with changing priorities under supervision

Anticipated salary range: $85,000-$105,000/year depending on qualifications 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 Cirtecs 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.