Senior Process Development Engineer

Job Title: Senior Process Development Engineer

Pay Rate: $60.00 - $65.00/hr

Duration: 2-3 months contract

Location: Hybrid; Minnetonka, MN

POSITION SUMMARY:

This position will lead efforts to design, develop, implement, and maintain processes and equipment used to manufacture existing products and products in development. Products include but are not limited to combination pharmaceutical/medical devices used for self-injection. Processes include but are not limited to mid to high volume complex assembly, packaging, and labeling.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

• Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product design
• Design and develop manufacturing processes and equipment that are lean and mistake-proof
• Develop equipment specifications and work with suppliers to quote, procure, and implement
• Develop process validation plans, lead the execution of plans, and document results in reports
• Lead cross-functional teams to develop pFMEA’s and other risk assessments and implement effective manufacturing controls
• Collaborate with Operations team to develop effective process work instructions
• Implement equipment calibration and maintenance plans/schedules
• Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions
• Develop and validate test methods used in manufacturing
• Lead cross-functional teams to develop and manage project plans and schedules
• Identify and implement continuous improvement projects compliant with change management procedures
• Develop cost of goods estimates and cost/benefit analyses
• Provide guidance and mentorship to other engineers and technicians
• Lead CAPA projects and problem-solving efforts

EDUCATIONAL REQUIREMENTS (degree, license, certification):

• Bachelor’s degree in Engineering or related technical field

YEARS OF EXPERIENCE:

• 5-10 years in process development or manufacturing

OTHER SKILLS AND ABILITIES:

• Experience in medical device, pharmaceutical, GMP, or regulated industry preferred
• Experience with process validation (IQ/OQ/PQ) preferred
• Experience with design and troubleshooting automated equipment preferred
• Six Sigma Black Belt preferred
• Proficient in the use of Minitab, MS Project, and SolidWorks preferred
• Experience with Lean principles and metrics, problem solving methodologies, DMAIC, SPC, process capability analysis
• Ability to communicate across all levels of the business and externally with customers and suppliers
• Ability to author technical plans and reports
• Ability to travel up to 10% as projects require

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.