Job Description

Industry: Medical Equipment / Devices

Job Category: Research & Development

The Senior Research & Development Engineer/Scientist will be responsible for being a technical lead on projects and working with Marketing to identify new product opportunities and define product specifications along with designing and developing new products. This position will function as part of crossfunctional project teams working on new product development. The ideal candidate has a solid understanding of Engineering concepts and can support the strategic and operational objectives of the business. Prefer skills include previous experience in regenerative medicine material science and polymer science.

Essential Job Functions:

Become an expert in company’s core technical competencies including collagen processing and surgical applications for medical devices based upon the company’s core technology platforms.

Develop excellent relationships with key surgeons in order to identify customer needs and opportunities for new products

Lead and manage efforts to perform technical feasibility assessment of new product opportunities.

Work with outside consultants vendors and subcontractors involved in the project to ensure protocols are adhered to and programs are kept on schedule.

Support the transition from product to development to manufacturing including technical training of personnel in order to ensure a smooth manufacturing start up.

Oversee R&D equipment maintenance and calibration program ensure appropriate activities are performance in accordance with established schedules.

Write and revise R&D procedures and provide training in accordance with R&D Training program.

Work closely with Marketing Sales and customers to create prototype products and develop new product specifications

Develop and maintain effective crossfunctional working relationships and provide support to Manufacturing Process Engineering Regulatory and Quality Assurance

Exhibit excellent communication skills in keeping senior management and the development team members informed about technical developments and issues

Provide guidance for project team members in following Design Control procedures

Effectively implement risk analysis and problemsolving skills along with techniques to identify potential issues and assess their impact while developing and implementing mitigation strategies and resolution plans

Ensure that all appropriate technical documentation drawings specifications are generated in compliance with company procedures and statutory requirements (e.g. US FDA and notified bodies)

Provide technical input for analysis of manufacturing or design changes to existing products

Effectively plan experiments and analyze data utilizing experimental design and statistical analysis software.

Effectively utilize Microsoft Office software to create reports spreadsheets and presentations. Plan and coordinate product design and development activities.

Initiate recommend or provide solutions through designated channels.

Assist with various special ad hoc projects and other duties as assigned

Ideal Candidate

Education Experience and Certification:

Bachelor of Science with a minimum of 6 years’ experience or Masters of Science with 5 years’ experience or PHD with 3 years and Degree in Biomedical Engineering Chemical Engineering Materials Science Engineering and or Chemistry

Experience in Research Development of medical devices based upon regenerative technologies along with extensive experience with Design Control GLP/GMP and ISO regulations

Requires solid knowledge of CAD design software package

Demonstrated history of technical creativity in medical device product development

Formal training or experience in implementation of Design Controls for Medical Devices

Ability to listen and clearly communicate verbally in writing and in person to people at various levels of the organization.

Ability to prioritize and multitask in a high energy fastpaced environment.

Exceptional problemsolving skills and proven track record of success

Advanced skills in Microsoft Office products such as Outlook Word Excel and Power Point or equivalent software applications.

Previous experience in research with materials derived from collagen or other animal tissue is a plus

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