Senior Product Development Engineer

Responsibilities

• Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, preclinical studies and extensive collaboration with internal and external partners.

• Create and maintain design control elements to comply with medical device regulations per ISO 13485 to support the development of products in accordance Product Development Process and Design Control requirements as well as compliance with Good Manufacturing Practices (Quality Systems Regulations), Standard Operating Procedures, and Safety requirements.

• Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.

• Maintain all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Verification Plans/Reports, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix

• Write and execute protocols to support development activities, execute experiments and analyze test data, interpret results and formulate conclusions and reports

• Prepare materials, design and execute studies including animal studies for safety and efficacy, product stability study, design verification, packaging validation.

• Lead the technology transfer of analytical methods from development to QC and spearhead analytical method qualification and validation.

• Responsible for identifying and partnering with external CROs for assay design, and qualification and validation for external assays

• Provide technical support for Regulatory submission and FDA review Requirements:

 Education:

BS degree in biomedical engineering or other science related discipline from an accredited university or college with strong background in biomechanics, Master’s degree preferred

 Experience:

5+ years of research and development of medical device based upon regenerative technologies in regulated industry • Essential: Formal training and experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations. Demonstrated expertise in biomaterials design and characterization, preclinical testing including mechanical test development. Mastery of regenerative principles and working knowledge with resorbable biomaterials. Preferred Skills: • Biomaterial formulation expertise for development and characterization testing tools and techniques to develop bench top test methods and animal models, preferably in orthopedics area • Technical leadership experience with biomaterials delivery system development, final packaging of materials and delivery components and scale-up is ideal • Strong hands on experience in injectable biomaterials/collagen-based device design and development • Self-motivated, and possess strong organizational skills, and outstanding written and verbal communication skills • A positive, team-player with an attitude to get it done is a must • Must be able to multi-task, meet tight deadlines, and prioritize changing demands in a fast-paced environment • Excellent analytical, problem-solving and decision making skills. • Experience in technical writing and use of statistical tools