Senior Engineer/Scientist

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.

WHY THIS ROLE MATTERS

The mission of this role is to translate complex pharmaceutical and medical device concepts into robust, scalable manufacturing processes that meet stringent regulatory standards and customer specifications. This position drives organizational value by ensuring seamless transition of development projects from feasibility through validation, directly impacting commercial readiness and time-to-market for critical healthcare products. Through rigorous application of statistical process optimization and Design of Experiments methodologies, the role establishes manufacturing excellence that reduces production risk and enhances operational efficiency. Additionally, this position strengthens organizational capability by providing technical leadership across cross-functional teams and mentoring engineering staff, building the deep process knowledge essential for sustained competitive advantage in the medical device manufacturing sector.

WHAT YOU'LL ACHIEVE

While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are:

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

On average this should be about 30% of your time. Among other things this means we expect you to:

• Execute equipment and process qualification and validation protocols
• Collaborate with Operations to scale up processes from development to commercial manufacturing
• Lead design, execution, and analysis of Design of Experiments (DoEs) to identify optimal process parameters
• Develop and optimize pilot processes that meet customer specifications and regulatory requirements
• Lead technical problem-solving efforts to resolve process challenges and improve efficiency

Establish technical project leadership across feasibility and development initiatives to deliver customer solutions, resulting in successful project execution and client satisfaction

On average this should be about 25% of your time. Among other things this means we expect you to:

• Partner with Business Development to create technical proposals for customer projects
• Manage multiple concurrent feasibility projects with competing priorities
• Identify new technical resources and approaches to expand capabilities and grow expertise
• Take independent ownership of large development and clinical projects from concept through completion
• Communicate project status and technical findings effectively to internal teams and clients

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

On average this should be about 20% of your time. Among other things this means we expect you to:

• Collaborate with Project Management, Operations, and Quality to complete key documentation tasks
• Create efficient batch records, materials specifications, and testing protocols
• Develop test methods, standard operating procedures, and batch records for manufacturing processes
• Maintain thorough and compliant laboratory notebooks documenting all experimental work
• Author documentation for equipment and process qualification and validation activities

Oversee clinical build execution and equipment implementation to support product development timelines, resulting in successful delivery of clinical materials and operational manufacturing capabilities

On average this should be about 15% of your time. Among other things this means we expect you to:

• Coordinate with cross-functional teams to ensure clinical material requirements are met
• Establish process control strategies for large development and clinical projects
• Oversee clinical builds ensuring adherence to specifications and timelines
• Lead and execute equipment qualification and implementation for new 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

On average this should be about 10% of your time. Among other things this means we expect you to:

• Share technical knowledge and best practices with team members
• May directly supervise technicians on specific projects or activities
• Provide experience and expertise to technicians and junior staff members
• Support professional development of junior team members through coaching and guidance

Necessary Skills:

• 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)

MINIMUM QUALIFICATIONS FOR THE ROLE

• 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

PHYSICAL, SENSORY, COGNITIVE, & NEUROLOGICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to stand and walk for extended periods during laboratory work and equipment operation
• Ability to lift, carry, push, and pull objects weighing 2-50 pounds regularly
• Manual dexterity for handling laboratory equipment, materials, and documentation tasks
• Visual acuity for close work including reading handwritten or typed material and adjusting focus
• Ability to stoop, bend, squat, kneel, and reach at, below, or above shoulder height
• Ability to maneuver in tight spaces between equipment and workstations
• Physical stamina to maintain consistent performance during full work shifts
• Ability to see and hear on a continuous basis as well as speak frequently
• Ability to work on even or uneven surfaces and move quickly when necessary

ProMed offers a generous benefits package including:

• 401k with company match
• Profit Sharing Program
• Medical Insurance
• Health Savings Account/Flexible Spending Account
• Dental Insurance
• Vision Insurance
• Life Insurance
• Paid Family Medical Leave and Long-Term Disability Insurance
• Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
• Pet Insurance

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.