Product Development Engineer I

Charter Medical; Winston-Salem (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(k) with company match

Health Insurance

Job summary

Charter Medical in Winston-Salem, NC seeks a Product Development Engineer I to drive development of single-use products for cell and gene therapy, bioprocessing, and pharma. You will work with customers, third-party developers, operations, quality, and leadership to deliver compliant products and documentation.

The role requires a biology/bioprocess background, five years in life sciences, and familiarity with ISO 13485, 21 CFR 820, and USP.

Qualifications

• Bachelor’s degree in Biological Engineering, Biomedical Engineering, Bioprocess Engineering, Materials Science, or related field.
• Five (5) years of life science industry experience, preferably with single-use systems.
• Experience with ISO 13485, 21 CFR 820, BPOG guidance, or USP requirements.
• Knowledge of biocompatible materials and their impact on bioprocessing.
• Experience with stage gate processes and managing technical projects.

Responsibilities

• Lead product development projects for single-use products in life sciences.
• Communicate project progress to leadership and cross-functional teams.
• Partner with Product Management, Research, and Commercial teams on designs.
• Provide technical support for market research and feasibility activities.
• Document experiments, trials, samples, and ideas in a lab notebook.
• Pursue IP opportunities through the IP program as needed.
• Adhere to design controls and stage gate process.
• Identify and evaluate new materials, components, and technologies.
• Develop and integrate new manufacturing processes and tooling as needed.
• Develop test methods and apparatus for new products.
• Scope project timelines and budgets accurately.
• Transfer designs to manufacturing through change control.

Skills

Project management

Team collaboration

Technical writing

Budget management

Education

Bachelor’s degree in Biological Engineering

Tools

CAD

3D modeling

Computational Fluid Dynamics

Job description

Charter - Winston-Salem
Winston-Salem, NC 27103, USA

Description

What we are looking for:

The Product Development Engineer I drives and supports development activities of new single-use products for emerging cell and gene therapy, blood transfusion, biotechnology, and pharmaceutical industries. They will regularly work with customers, 3rd party technology developers, internal operations, quality engineering, and business leaders to deliver new products and documentation in accordance with ISO 13485, 21 CFR 820, and applicable USP requirements.

1st Shift: Monday-Friday 8:00 am-5:00 pm

What you will do:

• Lead product development projects and activities for single-use products in emerging cell and gene therapy, blood transfusion, biotechnology, and pharmaceutical industries in accordance with the business strategy and emerging industry standards.
• Communicate project progress to leadership and cross-functional team members.
• Partner cross-functionally with Product Management, Research, and Commercial teams to develop new designs or technologies and articulate technical concepts to project stakeholders.
• Provide technical support for Product Management to support upstream market research and early feasibility activities.
• Document activities, experiments, trials, samples, and ideas in a lab notebook.
• Identify and pursue intellectual property (IP) opportunities through the IP program as needed.
• Adheres to established design controls and incorporates the stage gate process for development activities.
• Identifies and evaluates new materials, components, & technologies.
• Develops and integrates new manufacturing processes and related tooling, in conjunction with the validation team and manufacturing engineering, when needed for new product introductions.
• Develop test methods and apparatus for new products as needed.
• Accurately scope timelines and budgets of projects.
• Complete projects according to schedule and communicate changes effectively.
• Actively work with Operations stakeholders to transfer design to manufacturing through the change control process.

Who you are:

• Bachelor’s Degree in Biological Engineering, Biomedical Engineering, Bioprocess Engineering, Materials Science, or related field.
• Five (5) years of experience in the life science industry, preferably in a bioprocessing or biomanufacturing environment working with single-use systems and materials.
• Experience working with ISO 13485, 21 CFR 820, BPOG guidance, or applicable USP requirements.
• Knowledge of biocompatible materials and their potential impacts on bioprocessing and biological processes.
• Experience with stage gate processes and managing technical projects.
• Ability to understand the client’s needs, how the needs relate to project scopes, and how changes will affect other systems.
• Ability to translate client inputs into engineering requirements based on a technical skill set that includes writing or drafting technical documents.
• Familiarity with budgeting practices to manage project costs and budget management.
• Prior experience with raw material qualifications.
• Effective project management experience and presentation skills.
• Ability to work in a team environment.
• Demonstrated time management skills.
• Proficient computer skills using MS Office and MS Project.
• Experience with CAD, 3D modeling, & computational fluid dynamics software is desirable.
• Generous Paid Time Off
• Annual Bonus
• 401(k) with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability

Equal Opportunity Employer
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