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Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Process Engineer II is responsible for support of product development and manufacturing operations activities. The engineer will contribute to new product introductions by assessing the feasibility of, and developing, new manufacturing processes and equipment. The engineer will also drive innovations in existing products/processes via process monitoring, continuous improvement, and the evaluation and implementation of process changes in medical device manufacturing facilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Lead manufacturing process development as part of a cross-functional core team (Manufacturing, Product Development, QA/QC/RA, Engineering, Facilities, Materials Management, Finance, Marketing) to transfer implantable collagen and acellular tissue-based products/processes from R&D to full-scale manufacturing, following Design Control Procedures.

• 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 to establish a robust design space.

• Work independently with vendors/suppliers to establish raw material specifications for new and/or improved processes.

• Apply experience with manufacturing process equipment to lead the selection and/or design and development of equipment from prototype and full-scale manufacturing.

• Author & review, and execute Equipment IQ, OQ, and PQ, and Process Validation protocols and reports, as applicable.

• Provide subject matter expertise to support manufacturing objectives. Perform timely technical investigation and provide practical manufacturing solutions for complex CAPAS under appropriate regulatory guidelines for Medical Device Manufacturer.

• Support the business with proactive process monitoring and identification of opportunities for improvement.

• 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 FMEA 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 Assurance

• Provide technical input for analysis of process changes in the above areas.

• Contribute to department strategy and budget planning.

• Mentor and provide guidance to junior team members.

DESIRED MINIMUM QUALIFICATIONS

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

Education

• BS/MS in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Bioengineering, Materials Science, or equivalent.

Experience

• 3+ years of experience in medical device or pharmaceutical environment.

• Experience with Quality System Regulation (QSR), GMP, Change Control, 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 leading and implementing cross-functional projects.

• Experienced in transferring and launching new products in manufacturing, medical device experience in design control is a plus.

• 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. Lean six sigma certifications a plus.

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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