Sr. Mechanical Design Engineer

Senior Mechanical Design Engineer

The Senior Mechanical Design Engineer is primarily responsible for defining, designing, and developing components and assemblies for Class II and Class III medical devices and related accessories. Able to multitask and run multiple projects while meeting customer commitments. Required are strong analytical skills to understand customer requirements, foresee technical challenges and lead the definition of design solutions to meet customer needs. The Senior Mechanical Design Engineer leads the design efforts for medium to large scale programs, can work independently, act as a technical lead, and be a mentor to other engineers.

Key responsibilities include managing programs as the technical lead for the mechanical development of new designs, improving existing designs, and transitioning current and future designs into production. This includes transforming internal and external inputs into outputs, developing design requirements and specifications, creating test methods and corresponding test method validations, coordinating design verification activities, generating 3D models and engineering drawings utilizing SolidWorks, performing tolerance analyses, and communicating technical risks as they arise. Additionally, the role involves creating and checking completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and accuracy of calculations and dimensioning. The Senior Mechanical Design Engineer will also host design reviews with internal and external stakeholders, serve as a technical expert in phase or design reviews, evaluate feasibility of concepts, manage workload to support various projects, provide regular status updates to management and customer, and write / update work instructions, part specifications, verification protocols, and various technical documents.

This is not a remote position; it will be fully on-site in our Brooklyn Park, MN location (relocation is not available).

Must have a Bachelor's degree in an Engineering (STEM) discipline, minimum of 5+ years of work experience, ability to serve as the point of contact and technical lead on programs alongside SMEs and the project manager(s), experience and knowledge of working under quality management systems that meet governmental regulations such as FDA QSR, ISO 13485, the MDD relevant standards, and have knowledge cGMP, GDP principles and practices. Experience implementing Design for Manufacturability (DFM) principles into design, proficiency with CAD SolidWorks preferred, understanding of tolerance stack ups, DFM, and GD&T for proper design alignment in assemblies, good understanding of the product development process within the medical device industry, ability to multitask and support multiple projects while meeting customer commitments, and excellent reading, writing, communication, and organizational skills.

Anticipated annual salary range : Competitive market salary from $105,000 to $125,000 per 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.