Product Development Engineer I

Charter-Medical,-LLC-1; Winston-Salem (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid Time Off

Annual Bonus

401(k) with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Discount

Job summary

Charter Medical, LLC – Winston-Salem, NC – seeks a Product Development Engineer I to drive development of single-use products for cell and gene therapy, bioprocessing, and biopharma. You will coordinate with customers, QA, and operations to deliver compliant documentation and products.

The role emphasizes stage-gate development, IP opportunities, and cross-functional collaboration with Product Management, Research, and Commercial teams.

Qualifications

• Bachelor’s degree in a life science related engineering field.
• 5+ years of experience in life sciences, bioprocessing or biomanufacturing 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.
• Ability to translate client inputs into engineering requirements.
• Familiarity with budgeting to manage project costs.
• Experience with raw material qualifications.
• Strong project management and presentation skills.
• Ability to work in a cross-functional team.

Responsibilities

• Lead development projects for single-use products in life science industries.
• Communicate project progress to leadership and cross-functional teams.
• Collaborate with Product Management, Research, and Commercial teams on designs or technologies.
• Provide technical support for market research and feasibility studies.
• Document experiments, trials, and ideas in a lab notebook.
• Identify IP opportunities as needed.
• Adhere to design controls and stage gates.
• Evaluate new materials and technologies.
• Develop manufacturing processes and tooling with validation teams.
• Develop test methods for new products.
• Estimate project timelines and budgets.
• Complete projects on schedule and communicate changes.
• Support design transfers to manufacturing through change control.

Skills

Project management

CAD software

3D modeling software

CFD software

MS Office

MS Project

Budgeting

Team collaboration

Education

Bachelor’s Degree in Biological/Biomedical Engineering or related field

Tools

CAD software

3D modeling software

CFD software

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 form
• Paid Short Term and Long Term Disability

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.