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Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

Reporting to the Director of Process Engineering, this position is responsible for support of product development and manufacturing operations activities.  Assess feasibility of and assist in the development of new manufacturing processes for new and existing products.  Develop specifications for new manufacturing equipment, and implement such equipment for use within a medical device manufacturing environment.

SUPERVISION RECEIVED

Directly reports to Director of Process Engineering

SUPERVISION EXERCISED

None initially.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Work as part of a cross-functional team (Manufacturing, QA/QC/RA, Engineering, Facilities, Materials Management, Finance, Marketing) to transfer implantable collagen based products/processes from R&D to full-scale manufacturing, following Design Control Procedures.Lead and manage efforts to create novel processes, leading to full scale manufacturing of Integra Regenerative products.Perform hands-on laboratory work for prototyping, testing, DOE to optimize and scale-up processes from R&D to full-scale manufacturing.  Development of specifications for new processes.Work independently with vendors/suppliers to develop new equipment and establish raw material specifications for new and/or improved processes.Apply experience with manufacturing process equipment to lead the selection and/or design of equipment from prototype and full scale manufacturing.Work to gain expertise in Integra’s current technical proficiencies and manufacturing processes.Provide daily analytical and technical support to meet manufacturing objectives.  Perform timely technical investigation and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturer.Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.Train manufacturing personnel on new manufacturing processes and changes implemented to current manufacturing operations.Lead teams in performing and updating Process FMECA risk management.Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs.Generate technical documents/reports (engineering studies, validation, URS, FAT, production SOPs), compliance documents (ECO, DMR, batch records) and business documents (BOM, routings, standard costs, and Manufacturing Plans for new products).Ensure that all appropriate documentation, drawing specifications are generated in compliance with Integra’s procedures and statutory requirements (FDA and ISO)Develop and maintain an effective cross-functional working relationship with Manufacturing, Sustaining Engineering, Regulatory, and Quality AssuranceProvide technical input for analysis of process changes in the above areas.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education

BS/MS in Mechanical Engineering, Bioengineering, Pharmaceutical Engineering, Chemical Engineering, Materials Science, or equivalent.Use of statistical process tools highly desired: Minitab, Six Sigma, Lean are a plus

Experience

5+ years of experience in medical device or pharmaceutical environment.Experience with Quality System Regulation (QSR), GMP, Design Control, and Process Validation guidelines applied to the Medical Device industry.Knowledge of validation fundamentals (IQ/OQ/PQ), statistics and process capability (CpK, sampling methodologies, etc).Experience in clean rooms, lyophilization or biomaterials are desirable.General chemistry, processing and materials expertise.Exceptional problem solving skills.Practical product fabrication a plus.Use of statistical process tools highly desirable, Minitab a plus.

TOOLS AND EQUIPMENT USED

Be fully versed in the use or Microsoft Office software and tools (Outlook, Project, Powerpoint, Word, & Excel) and use of statistical tools.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak.  The employee is required to go to all areas of the company.  The employee may be required to periodically lift and/or move up to 20lbs.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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