Principal 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 Principal Process Development Engineer is primarily responsible for supporting the Process Development Engineering team as a subject matter expert in defining and developing manufacturing processes for medical devices and associated auxiliary equipment. This role will deploy Best In Class methods for process characterization, process validation, and process improvement opportunities; and collaborate across the Cirtec Medical organization, working with Manufacturing Engineering, Quality Assurance, and Applications Engineering to deliver superior manufacturing processes. The Principal Process Development Engineer is the technical lead and mentor to other Process Development Engineers, and will assist management in teaching, guiding, mentoring, and providing technical direction to the Process Development Engineering team.

ESSENTIAL RESPONSIBILITIES

• Oversee and provide technical direction over Development Engineering of medical device manufacturing processes and transfer to production via:

  o Plan and lead process design initiatives that define, characterize, optimize, and validate stable, robust, and capable processes for product commercialization.

  o Create test methods and corresponding test method validations.

  o Lead PFMEA creation and supporting risk management activities.

  o Coordinate process qualification activities (i.e., IQ, OQ, PQ).

  o Define requirements and design criteria, then develop, document, and qualify new (or improve existing) equipment, tooling, and fixturing.

  o Advise internal and external customers in Design for Manufacturability.

  o Understand the functional performance of manufacturing processes as they are developed.

  o Write/update work instructions, part specifications, protocols, and technical documents.

  o Maintain compliance to procedures and regulatory requirements.

  o Communicate technical risks as they arise.

  • Research, evaluate and recommend equipment, technologies, material, and methodologies that improve quality, reduce costs, and decrease program development time.

  • Assist, as an available resource, Business Development and Applications Engineering in quoting and proposal development.

  • Exercise creative problem solving and critical thinking; oversee the planning and execution of DOEs/characterization studies, analysis, interpretation, and documenting and reporting of data.

  • Lead and teach analytical techniques and apply engineering principles to understand the impact and interaction of materials and processes on process and product outputs.

  • Lead cross-functional teams in collaborative efforts to research, define and develop new manufacturing processes and improve existing processes.

  • Serve as technical expert in phase or design reviews with internal and external stakeholders.

  • Improve the engineering development process and systems based on experience and feedback.

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

  • Provide technical subject matter expertise and oversee management and partnerships with external suppliers by executing due diligence assessments, setting specifications for critical quality and/or manufacturing attributes for materials and components, collaborate on development projects and qualification/validate external processes.

  • Mentor and educate engineers and technicians in various functions; and communicate technical knowledge cross-project to reduce tribal knowledge.

  • Understand the complete product development process within the medical device industry (Class II & III).

  • Provide regular status updates to management and/or customer.

  • Support project teams with technical problem solving and expert opinion.

  • 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 10 years of experience required; or a combination of education and relevant work experience.

  • Experience and knowledge 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.

  • Familiarity with CAD required, SolidWorks preferred.

  • Experience with robust process documentation (IQ/OQ/PQ, PFMEA, process flow) required.

  • Knowledge of dimensioning and tolerances, GD&T.

  • Computer skills associated with Microsoft software.

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

  • Excellent reading, writing, communication, and organizational skills.

  • Possess team collaboration skills.

  • Strong mechanical aptitude.

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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