Product Development Engineer II

17 hours ago

Indianapolis, United States BioLife Solutions Full time
Job DescriptionJob DescriptionSalary: DOE + Excellent Benefits

BioLife Solutions is repeatedly named one ofWashingtons 100 BestCompanies 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 whereauthentic 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 II will lead the translation of market requirements into product concepts and
design requirements. They will be responsible for designing a platform of 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 role will be assigned projects in both development and sustaining engineering and work with the crossfunctional team to deliver the projects on time and within budget.


Duties and Responsibilities:
The Product Development Engineer II will have responsibility for the design and development of all single-use
consumables, including but not limited to the items listed below:

  • Establish 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.
  • Create 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.
  • Lead technical risk assessments and if necessary, establish mitigation plans to minimize product risks.
  • Manage day-to-day activities of small engineering team to complete technical projects according to
    established budgets and timelines.
  • Author technical documents (ex. test protocols, reports) demonstrating products are compliant with
    requirements. Approve documents authored by other team members.
  • 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


Job Requirements:

  • Demonstrated technical knowledge of mechanical engineering principles including plastics design,
    materials science, 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.
  • Demonstrated experience with Product Development Process, Risk Management, Root Cause Corrective
    Action, and Quality Management Systems.
  • Experience with materials, specifically plastics, is preferred.
  • Domestic travel up to 20%.


Job Specifications:

  • Bachelors degree in Mechanical or Biomedical Engineering.
  • 5 7 years of experience in product development with expanding responsibilities.
  • Demonstrated experience in technical project management.
  • Familiarity with cell and gene therapy industry is preferred.


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.BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.
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.

Our salary ranges are determined by position, level, location, and market competitive benchmarks. Individual pay within a level is determined by work location (including geographic pay zone region), job related skills, experience, education, and training.


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