Job Summary
- Location
- Plainsboro, NJ 08536
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Job Reference Code
- 1672
Principal Engineer (IRC1169)
About the Job
Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Integra has increased revenues over 40% annually over the last 10 years. We anticipate our significant growth to continue as we celebrate 20 years of clinically relevant, innovative and cost-effective products. In 2005, 2006, and 2008 Integra LifeSciences was named to the Forbes 200 Best Small Companies list. In 2007 Integra was named Medical Device Manufacturer of the Year by Medical Device & Diagnostic Industry Magazine, and was selected as the New Jersey Technology Council's Master Technology Company of the Year.
SUMMARY DESCRIPTION
Reporting to the Engineering Manager, this position is responsible to execute & manage project assignments in the evaluation, selection, and application of various engineering techniques, procedures, and criteria with minimal supervision. Independently plans, schedules, and leads detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Solves basic and complex problems identified through process characterization, monitoring & trending. Apply innovative approaches in the development of new processes, equipment, & systems. The incumbent should be able to complete complex design and engineering tasks and manage projects with little assistance. This includes constructing detailed, accurate project schedules, interfacing with internal and external engineering & technical resources in solving project problems, and having the ability to prioritize multiple projects and tasks.
SUPERVISION RECEIVED - Directly reports to the Engineering Manager
SUPERVISION EXERCISED - Various
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
? Responsible for process engineering and project management to support improvement of existing processes, and introduction of new product & processes. These projects are typically higher level capital projects with increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly.
? Responsible for liaising with Product development group to provide plant input in the product development process, to include but not limited to, design requirements, risk analysis, traceability matrix, design history file, etc.
? Responsible for total Project management, process development, process improvement, IQ/OQ/PQ validations, and Manufacturing process troubleshooting. Must be able to manage the project in its entirety, and be able to perform / deliver specific project tasks as necessary.
? Responsible for analysis and upgrade of utility systems when needed (WFI, DIUF, Lyophilizers, HVAC, CCA, & steam generation)
? Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
? Provide daily analytical and technical support to meet manufacturing objectives.
? Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
? Work closely with Development Engineers, Marketing, Sales, and Clinical colleagues to ensure smooth transfer of product and process scale-up.
? Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full scale manufacturing
? Lead teams in performing and updating Process FMECA risk management
? Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities
? Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, and Engineering) and supporting members (Corporate Regulatory, Finance, etc.). Includes such tasks as development of Manufacturing requirements, accounting documentation, specifications, validations, and Engineering drawings and ECN paperwork.
? Ensure that all appropriate documentation, drawings specifications are generated in compliance with Integra?s procedures and statutory requirements ( US FDA and ISO)
? Responsible for process scale up to plant standards and manufacturing volumes.
? Provide technical input for analysis of process changes
? Develop P&ID and PFD as required
? Working knowledge of Automation & PLC required
? AutoCAD experience required
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required.
? MS in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or equivalent.
? Minimum of 15 years experience in the medical device, pharmaceutical industry, or chemical industry with experience in process development.
? Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, QSR, ISO, and Design Control and Regulatory procedures is required. Experience in clean rooms, Lyophilization a plus.
? Experience in biomaterials desirable.
? General chemistry, processing and materials expertise
? Exceptional practical problem solving skills, excellent organizational and communication skills
? Practical product fabrication a plus.
? Use of statistical process tools highly desirable. Minitab a plus.
? Six Sigma training highly desirable
? PE certifivcation a definite plus.
We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.
To find out more about our company, visit our website at: http://www.integra-ls.com
No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V
Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.
Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.
Please click the following URL to apply for this job https://erpiapps.integra-ls.com/OA_HTML/OA.jsp?OAFunc=IRC_VIS_VAC_DISPLAY&p_svid=1169&p_spid=33289&p_site_id=21
