AlloSource

Compensation

Full Description

Would you like to develop your skills working for a mission-driven organization while playing an important role in leading the way in Life Sciences? AlloSource is a BioTech company headquartered in Centennial, Colorado. Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families and helping patients heal through our innovative cellular and tissue allografts. This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life! What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life! If this sounds like an organization you wish to be a part of, then we invite you to apply. Summary: The Senior Engineer – R&D serves as a technical subject matter expert in new product development within an FDA-regulated tissue processing environment. This role leads and supports all phases of the product lifecycle—from concept generation and feasibility through design, validation, and commercialization—ensuring compliance with regulatory requirements and alignment with manufacturing capabilities. The Senior Engineer provides cross-functional technical leadership and collaborates closely with Marketing, Operations, Manufacturing Engineering, Quality Assurance, Regulatory Affairs, and Business Development to bring innovative, safe, and effective tissue-based products to market. This role also plays a key part in process development, risk management, and design control activities to support the successful launch and lifecycle management of new products. Anticipated Application Deadline: September 19, 2025 Pay: $72,419 - $95,497/yr based upon relevant years of experience Shift: Monday – Friday; 8:00am to 5:00pm; Hybrid schedule, working three days in the office Benefits: Medical, Dental, Vision, Life Insurance. Click link for more details: 2025 AlloSource Employee Benefits Summary Location: 6278 S Troy Circle Centennial, Colorado 80111 Essential Duties and Responsibilities: • Drive the design and development of new human tissue and medical device products as the subject matter expert and technical lead, overseeing all phases from concept through design freeze, verification, validation, and commercialization. • Develop functional prototypes and proof-of-concept models to evaluate design feasibility, gather user feedback, and support iterative product development. • Facilitate integration of new products and processes into manufacturing, with a strong focus on scalability, efficiency, and long-term manufacturability. • Drive new product development initiatives, including product design, process optimization, major process improvements, characterization studies, equipment/tooling development, and validation activities. • Identify, assess, and mitigate technical and regulatory risks throughout the product development lifecycle, leveraging risk management tools and cross-functional collaboration. • Develop and implement innovative methodologies, materials, equipment, and processes that enhance product performance, improve quality, or reduce cost, in compliance with FDA and internal quality system requirements. • Design and execute scientific studies and technical investigations to support product development, validation, and regulatory submissions, including protocol development, data analysis, and reporting. • Author and review technical stage gate documentation, as required, including technical project plans, product / process characterizations studies, work instructions and processing records, validation plans, study and validation protocols/reports and pilot runs. Ensuring compliance with design control procedures. • Develops, maintains and leads relationships with suppliers, customers, and other vendors as projects require. • Collaborate closely with cross-functional teams (e.g., Quality, Regulatory, Manufacturing, Marketing, Project Management) to ensure alignment with business goals and overall company strategy. • Write or assist in writing intellectual property (invention disclosures / patents) to support AlloSource intellectual property portfolio. • Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies. • May perform other related duties and responsibilities as assigned. Requirements • Bachelor’s degree in biomedical engineering or related field • Minimum 3-5 years’ experience in Product Development. • Proficiency in Microsoft Office applications • Ability to communicate in English proficiently (speaking, reading, writing, and comprehension) Preferred Experience: • Master’s degree in Engineering • Experience in FDA regulated industries such as Tissue Banking, Medical Device, Biomedical or Pharmaceutical • A demonstrated capacity for developing and commercializing innovation • Experience Design Controls and a phased approach for new product development. • Previous training or experience with root cause analysis, lean six sigma, statistical techniques, and/or quality system It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. For consideration you must apply online, submit a current resume and meet the minimum requirements. AlloSource is a Fair Chance Employer. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.