Sr. Applications Engineer

Cirtec Services GmbH; Brooklyn Park (MN); Sur place; USD 100 000 - 135 000; Plein temps

Résumé du poste

Cirtec Medical Corporation is seeking a Sr. Applications Engineer to generate proposals for mechanical devices and high-precision components, while supporting teams in implantable product development.

You’ll collect and organize cost data for complex development proposals and build networks to analyze new opportunities. The role requires hands-on experience in medical device development from design to production, strong ISO 13485 and FDA 21 CFR 820 knowledge, and the ability to read technical

Qualifications

• Bachelor's degree in a STEM field required.
• 5+ years of Applications Engineering experience.
• Experience in mechanical/tool design and manufacturing (medical devices preferred).
• Experience on medical device development projects from design through production.
• Strong understanding of ISO 13485 and FDA 21CFR820 Quality Systems.

Responsabilités

• Collaborate with cross-functional teams to define development plans and budgets.
• Evaluate technical solutions for customer development requests.
• Prepare budgets and quotations for development programs.
• Write proposals with clear technical communication and visuals.
• Lead peer reviews and management reviews for proposals.
• Provide technical leadership to program teams.
• Support technical strategies and risk assessment for PDP programs.
• Guide teams through Cirtec's Product Development Process for mechanical assemblies.

Connaissances

5 years experienc e in Apps Eng

Mechanical design

Tool design

Manufacturing processes

Medical device development

ISO 13485 & FDA 21 CFR 820

Reading drawings

Fluent English

Willingness to travel

MS Office

Formation

Bachelor's degree in STEM

Outils

MS Office

Description du poste

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. Applications Engineer has two main responsibilities: (1) generating proposals for engineering projects involving mechanical devices, value-added assemblies, and high-precision components, and (2) supporting technical teams as they work to develop implantable products. The position will also support other Applications Engineering staff with collection and organization of cost data for complex development proposals. The Senior Engineer completes tasks with limited autonomy but is able to build and manage a network of internal resources to thoroughly analyze and create proposals for new opportunities.

Key Responsibilities:

• Collaborates with cross-functional engineering teams to assess and document technical development plans, incorporating knowledge of both existing and new assembly processes and techniques.
• Applies engineering skills and know-how to evaluate and recommend technical solutions to customer development requests.
• Participates in definition of requirements, scope, timeline, and budget for new development programs. Supports others in the development of budgetary project plans, development proposals, and quotations for both new and existing customers.
• Writes proposals for development programs with clear technical communications skills using a variety of visual and written techniques (e.g. graphs, diagrams, long-form writing).
• Gather peer review on written proposals and participate in management reviews of the proposals to get required approvals.
• Provide technical leadership and guidance to program team members
• Support program teams in developing technical strategies, feasibility workflows, evidence-based development processes.
• Provide risk assessments of development data and support program teams by asking for and guiding them through data-based decision-making.
• Guide program teams through technical deliverables of Cirtec's Product Development Process for mechanical assemblies.
• Working with Business Development, act as customer-facing representative in the support of proposals for new development business, including the scoping of new potential programs.
• Working with Applications Engineering management, recommend problem solving approaches, proposed designs, and proposed resource needs to write proposals for new development business.
• Participate in regular technical reviews of ongoing programs and proactively bring attention to signals of development risks in new and ongoing PDP programs.
• Recommend additional technologies and/or support internal technical development of standard products that may support PDP programs in speed or cost to execute.
• Actively participate in training younger development staff to improve product development, communication, and documentation skills.
• Participate in continuous improvement of Cirtec's design control procedures and internal business processes.
• Communicate with vendors and suppliers for sourcing and development of new components.
• Analyze internal manufacturing and supply chain data to assess actual costs and estimate future production costs

Must Have:

• A Bachelor's degree in a STEM related field
• 5 years of experience in Applications Engineering required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
• Must have experience working on medical device development projects from design through transfer to production
• Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
• Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
• Must have proficiency in MS Office software
• Must be able to read, write and speak fluent English
• Willingness to travel, if required

Good to have:

• Experience with active implant devices or implantable components

Salary Range: $100,000 to $135,000 depending 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.