Engineer, R&D


Job ID 18-00086

Industry Pharma

Job Type Permanent

Location Edison, NJ

Description

Overview/Risks
Develop new products, processes and packaging within the Company Design Control System. Drive the scale-up of process, product and packaging development activities for transition from R&D to Manufacturing, taking responsibility for one or more critical aspects of the product development life cycle. Work with Surgeons to conduct handling labs for new product designs and participates in studies conducted at University sites or contract laboratories.
 

Responsibilities
1. Responsible for development of new products, product improvement and line extensions for products. Activities include design, material selection, prototyping, testing, process development, equipment validation, process qualification and validation, and packaging/stability studies. Responsible for combining, analyzing and synthesizing data from multiple experiments and sources to make engineering recommendations. Utilizes statistical methods in data analysis.
a. Interacts with manufacturing, product managers, quality engineering, regulatory affairs, project management, and other functional departments to define and develop product requirements and concepts.
b. Coordinates study activities with external contract laboratories or with University sites performing sponsored research for Company.
c. Works directly with surgeons for design concept development, prototype and cadaver evaluation,
d. Coordinates the fabrication of prototype samples for handling and cadaver labs with surgeons and strategic partners.
e. Coordinates activities to produce samples and documentation for products to be used in animal studies and human clinical evaluations.
2. Maintain a current knowledge of the state of the art for allograft tissue and medical device science. Track progress of competitive technology and applies this knowledge to development of new Company tissue forms.
3. Develop mechanical, physical, chemical or biologic analytical test methods and test protocols; guide and coordinate associate engineers and technicians in performing tests and recording information; generate, analyze and review reports required to meet Design Control requirements.
4. Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control Regulations, and to support regulatory filings (i.e. 510 (k) or clinical evaluation.
5. Responsible for engineering-scale process design, process development, process flow mapping and process equipment development as part of new product development, and product or process improvement.
6. Transfer product, process and packaging development to the manufacturing and quality organizations as part of scale-up activities including training, documentation, and validations.
7. Plan Design of Experiment (DOE) activities. Participates in development of patents and review of patent literature
8. Identifies external vendors for specific supplies and equipment associated with a product development project requirements and coordinates activities with vendor and Company Supply Management
9. Travels approximately 10-15% of time to monitor studies at external study sites (contract laboratories, university research labs), attends medical conventions, and to attend Surgeon Advisory Board meeting for the purpose of making presentations as required.
10. Assist on special projects and performs additional duties as assigned.



Qualifications

Qualifications
MINIMUM JOB REQUIREMENTS

Education: Bachelor's degree in engineering discipline (e.g. Mechanical, Biomedical, Chemical, Materials Science)
Experience:
Bachelor's degree with 2-5 years experience in a regulated industry.
Master's degree with 2+ years experience in a regulated industry.
Specialized Knowledge, Skill, and Abilities*:
Proficient in Microsoft Word, Excel and Project and basic statistical analysis.
Strong written and verbal communication skills.
Ability to work within a multifunctional team environment.
Work Environment: Office Environment, Laboratory Environment, & Occasional Clean Room Access
Physical Demands: Travels approximately 10- 15%, Gowning into a clean room environment when needed
 

PREFERRED QUALIFICATIONS
Experience:Medical device, pharmaceutical or other GMP-regulated industry experience.
Specialized Knowledge, Skill, and Abilities:
Knowledge of test design software and knowledge of CAD design software associated with solid modeling and drafting
Experience with mechanical testing of materials
Provided guidance or coordinated activities of technicians.