Integra LifeSciences Corporation
Location
Columbia, MD | United States
Job description
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
Changing lives. Building Careers.
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.
This position 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
7+ 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 significant 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.
TRAVEL
Periodic travel to Integra manufacturing sites, suppliers and conferences is required.
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 (minitab) and CAD (i.e. solidworks).
Lab equipment: Comfortable using engineering measurement devices: multi-meter, thermal mapping, data loggers, as well as various lab and bioprocess equipment.
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. Must be able to work in a cleanroom / controlled environment with gowning.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of the position, which is that of a general plant environment.
Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.
SELECTION GUIDELINES
Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.
DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
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.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
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 [email protected] or call us at 855-936-2666.
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