Senior Engineer/Scientist

PROMED MOLDED PRODUCTS INC•Maple Grove, MN

4d•$115,135 - $158,886

About The Position

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best. ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world. Working as one to help many.

Requirements

Demonstrable working knowledge of Design of Experiments (DoE) methodology and statistical analysis
The ability to work independently while collaborating effectively with cross-functional teams including Business Development, Operations, Quality, and Project Management
Previous experience with process development, equipment implementation, and process control in pharmaceutical or medical device manufacturing
Bachelor's degree in engineering or physical science field with at least 6 years of experience, Master's degree with at least 3 years of experience, Ph.D., or 9 years of experience in a regulated environment in lieu of education requirements
The ability to manage multiple concurrent projects and priorities in a fast-paced development environment
Previous experience developing technical documentation including batch records, SOPs, and validation protocols

Nice To Haves

Design of Experiments (DoE) (Expert)
Process Development and Optimization (Expert)
Equipment Qualification and Validation (Expert)
Technical Documentation (Expert)
Statistical Analysis Software (Expert)
Polymer Processing (Proficient)
Pharmaceutical Processing (Proficient)
Combination Medical Device Development (Proficient)
Regulatory Compliance (FDA/ISO) (Proficient)
Project Management (Proficient)
Technical Problem-Solving (Proficient)
Cross-Functional Collaboration (Proficient)
Data Analysis and Synthesis (Proficient)
Technical Writing and Reporting (Proficient)
Laboratory Notebook Maintenance (Proficient)
Process Scale-Up (Proficient)
Test Method Development (Proficient)
Client Communication and Presentation (Proficient)

Responsibilities

Drive process development and optimization for combination medical devices and pharmaceutical products to enable efficient manufacturing, resulting in validated processes that meet clinical and commercial production requirements
Establish technical project leadership across feasibility and development initiatives to deliver customer solutions, resulting in successful project execution and client satisfaction
Create comprehensive technical documentation and manufacturing specifications to ensure process consistency and regulatory compliance, resulting in complete batch records and quality systems that support production operations
Oversee clinical build execution and equipment implementation to support product development timelines, resulting in successful delivery of clinical materials and operational manufacturing capabilities
Provide technical mentorship and guidance to junior staff and technicians to build team capabilities, resulting in enhanced team performance and knowledge transfer across the organization