Job Information
Cirtec Medical Senior Applications Engineer in Brooklyn Park, Minnesota
Senior Applications Engineer
Department: BP - Engineering
Location: Brooklyn Park, MN
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This position is eligible for a $5,000 sign on bonus.
This position is located on-site based out of our corporate headquarters in Brooklyn Park, MN.
ABOUT THE COMPANY:
More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today-s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization. Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers- devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!
YOU ARE A PART OF:
The engineering team consisting of other engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.
JOB SUMMARY:
The Senior Engineer, Applications 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.
ESSENTIAL 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
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
This is not a remote position. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
QUALIFICATIONS:
A Bachelor-s degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
Experience generating proposals for engineering projects involving mechanical devices, assemblies, and high-precision components, and supporting technical teams as they work to develop implantable products.
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
Experience with active implant devices or implantable components preferred
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
WHAT WE OFFER:
A fast-paced work environment
Paid time off401(k) retirement savings with a company match
Clean, and well-lit production areas
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
WORKING ENVIRONMENT:
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
EEO STATEMENT:
Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer 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.
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