Senior Process Development Engineer

Department: BP - Engineering

Location: Brooklyn Park, MN

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This position is eligible for a $5,000 sign on bonus.

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 consists of 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 Sr. Engineer, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the

design, development, documentation, and validation and 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.

ESSENTIAL RESPONSIBILITIES

• Attends and arranges project meetings to discuss current and future design and development

  initiatives

• May serve as a primary contact with clients on projects of moderate complexity

• Assist with preparation of proposals and quotations for clients; interface as needed to resolve

  questions in a timely manner

• Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and

  medical device quality regulations with required actions. Track and communicate project status,

  plans, issues, timelines, action items, and budgets

• Provide guidance and direction to coworkers on areas of technical expertise

• Troubleshoot production processes as required

• Evaluate and select appropriate test methods for product requirements

• Responsible for the following project inputs:

  o Feasibility builds, documentation, and testing,

  o Equipment selection, process development and documentation,

  o Device Verification samples and testing,

  o Operator training,

  o Process Failure Mode Effects Analysis,

  o Clinical builds,

  o Process Validation

• Involvement in the full design, development, and validation requirements of projects, including:

  o Product design and specification creation, including mechanical and electrical components,

  assemblies, and packaging,

  o Materials sourcing and device prototyping,

  o Design verification and validation activities, including data for regulatory submission,

  o Manufacturing transfer and support of existing product lines as applicable

• 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 in an engineering environment with mechanical, tool/fixture design, and manufacturing

  processes

• Experience with Class II or III medical device development.

• Experience in leads design and development or value added assemblies preferred.

• Willingness to travel, if required.

• Must maintain high ethical standards

• Must demonstrate good organizational skills.

• Ability to train new engineering employees on project engineering activities and Cirtec policies and

  procedures.

• Must be able to read, write and speak fluent English.

• Strong computer skills, including the MS Office suite and MS Project.

• Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written

  documents.

• Strong analytical skills

• Must be able to obtain and evaluate secondary research information.

• Ability to learn and apply new technology.

• Moderate knowledge of engineering principles, technical writing, material properties, good tooling

  practices, and statistics.

WHAT WE OFFER

• A fast-paced work environment

• Paid time off

• 401(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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