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Product Development Engineer
3 months ago
BioLife Solutions is repeatedly named one of Washington’s 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes generous company stock awards and a 401k matching program.
BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor® freeze media and HypoThermosol® shipping and storage media, ThawSTAR® family of automated, water-free thawing products, evo® cold chain management system, and Custom Biogenic Systems high-capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit: www.biolifesolutions.com.
General Summary and Purpose:
The Product Development Engineer I will support the translation of market requirements into product concepts
and design requirements. They will be responsible for designing a variety of products ranging from laboratory
equipment for fluid handling to single-use consumables to support cell and gene therapy manufacturing. In
addition, the role will be responsible for verifying products meet requirements, developing production methods,
and supporting activities required to bring products to market. The product development engineer will be
assigned projects in both development and sustaining engineering and work with the cross-functional team to
deliver the projects on time and within budget.
Duties and Responsibilities:
The Product Development Engineer I will have responsibility for the design and development of products
assigned, including but not limited to the items listed below:
- Participate in establishing design input requirements to ensure products satisfy customer requirements.
- Generate design concepts for single-use consumables and other similar products. Test product feasibility
against requirements. - Support the creation of project schedules and budgets for new product development activities.
- Develop product designs, prototypes, test plans, and manufacturing processes that will ensure a safe,
effective, and marketable product. - Execute design changes for commercially available products to improve reliability and/or reduce cost.
- Perform technical risk assessments and if necessary, establish mitigation plans to minimize product risks.
- Manage and complete technical projects according to established budgets and timelines.
- Author technical documents (ex. test protocols, reports) demonstrating products are compliant with
requirements. - Assure regulatory and quality requirements are followed and fulfilled.
- Comply with department processes and procedures, including Design and Development Stage Gate
process.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at
any time with or without notice.
Reporting Relationships:
This position reports to Global Vice President of Engineering, Indianapolis, IN
Job Requirements:
- Demonstrated technical knowledge of mechanical engineering principles including fluid dynamics,,structural design, design for manufacturability, and systems integration.
- Proficient in CAD systems for product design; SolidWorks preferred.
- Strong verbal and written communication skills.
- Highly motivated, goal oriented, and able to work independently.
- Good interpersonal skills and demonstrated ability to work within cross-functional teams.
- Working knowledge of Product Development Process, Risk Management, Root Cause Corrective Action,
and Quality Management Systems. - Experience with materials, specifically plastics, is desirable.
- Domestic travel up to 20%.
Job Specifications:
- Bachelor’s degree in Mechanical or Biomedical Engineering.
- 4 – 6 years of experience in product development.
- Demonstrated experience in technical project management.
- Familiarity with cell and gene therapy industry is desirable.
BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.
BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
The BioLife Solutions total rewards program includes, but is not limited to medical, dental, vision, 401K with generous match, life and disability insurance as well as time off programs of Vacation and Sick time. Additionally, we believe in our team members sharing the success of our business and therefore we may provide cash bonus or stock equity grants based on company performance as a part of our total rewards package.
