Product Development Engineer I

Solesis•Winston-Salem, NC

7d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Experience with CAD, 3D modeling, & computational fluid dynamics software is desirable.

Responsibilities

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.