Process Development Engineer II – Medical Device (Maple Grove, MN — Onsite) Contract - Mid-level

Job Role : Process Development Engineer II Medical Device (Maple Grove, MN Onsite) Contract - Mid-level

Overview :

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues.

We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology.

Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at and follow us on LinkedIn :

Our Fortune 500 Medical Device client has an exciting opportunity for a Process Development Engineer II.

Job Summary :

The Process Development Engineer II will develop products, materials, processes, or equipment for projects of moderate complexity.

Under limited supervision / guidance, they will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

About the Role :

• The candidate must be a highly motivated and experienced engineer with expertise in new product development to lead the design and commercialization of new cutting-edge technology and products.
• The candidate must have a desire to utilize their skills to solve technical / complex problems in a hands-on manner, working in a fast-paced environment, and across multiple functions in a global company.
• Be part of one of the fastest growing divisions (Left Atrial Appendage Closure) supporting process development for exciting new products, and business development activities.
• Use your technical and collaboration skills alongside your passion for innovation and continuous improvement to drive growth through efficient and effective commercialization of new products and targeted improvements.
• This position offers the opportunity to support process development and product commercialization throughout a global plant network.
• Works cross-functionally to lead process development of complex technologies on new products, drive / develop new business activities and rapid prototyping execution, and ensures efficient and effective transfer of product into production.

Responsibilities :

• Collaborates cross functionally to develop robust designs and processes.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on projects.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling, and / or automated equipment.
• Writes clean and concise manufacturing work instructions that can be understood by product builders.
• Writes technical reports, validations, and qualifications by capturing experimental results.
• Writes validation protocols and reports applicable to new processes.
• Executes experiments, analyzes results using standard statistical methods, reports out recommendations, and generates next steps to improve performance, process efficiency, and technical understanding.
• Gathers and provides technical data for technical reviews.
• Assists in completing proper documentation to meet quality systems requirements. (e.g., BOM’s, Routers, Process Risk Analysis, etc.)
• Oversees development builds associated with the project using special work requests.
• Assists in developing qualified production lines.
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Contributes ideas to or generates Intellectual Property submissions.
• May train manufacturing personnel when required as part of a validation.

Quality Systems Duties and Responsibilities :

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Qualifications :

• 2-5 years' experience with BS in Engineering field.
• Industry related experience (internships, co-ops can be included in 2-5 years of experience).
• Statistical background
• Candidate will need to have the ability to work cross-functionally and with other sites in order to be successful.

Preferred Qualifications :

• Highly motivated individual that can independently drive deliverables to completion through collaboration among team members and internal support staff.
• Basic understanding of DFM, medical device design control, quality systems, and the product development process (PLCP) is highly desired.
• Strong statistics background
• MINITAB experience a plus!

Other Details :

• Schedule : Flexible start and end times : 7 : 30 / 8 : 00 AM to 4 : 00 / 5 : 00 PM are acceptable.
• Contract Length : 12 Months (Possible temp to hire)
• Set-up : Onsite in Maple Grove, MN

EEO Employer :

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact .

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients.

When you join Pharmavise, you become part of a team that values Excellence Through Quality.

E-Verify Participation :

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.

S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue.

For more information on E-Verify, please contact DHS at or through their website at dhs.gov / e-verify.