Integration Engineer - Regenerative Medical Device
Position Summary/ Objectives
The Supervisor, Integration Engineer will be responsible for supporting the engineering and development activities of new and existing products. The ideal candidate has a solid understanding of manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.
Essential Job Functions:
- Utilize understanding of Design Control Procedures to support projects from concept to launch including: laboratory activities for prototyping and testing; transfer of processes to manufacturing; and support the creation of technical documents.
- Develop and implement validation protocols. Write or revise standard operating procedures
- Work independently or in support of other engineers/scientists in troubleshooting technical issues encountered during prototyping, scale-up and manufacturing of products.
- Develop, design and conduct experiments along with analyzing data to support research projects. Summarize results in a formal report.
- Support sterilization validation program.
- Support new packaging design and validation
- Maintain quality records of experiments, including lab notebooks, logbooks, project binders, reports, etc.
- Support equipment maintenance and calibration program including performance of equipment qualification, calibration and maintenance.
- Assist in training personnel in the performance of their job in a safe and efficient manner and in GMP, QS and ISO regulations.
- Perform other related duties and responsibilities as assigned or required.
- Identify and record any problems relating to the product, process and quality system.
- Assist with various special ad hoc projects and other duties as assigned
- Initiate action to prevent the occurrence of any nonconformities relating to product and process.
- Initiate action to improve product and process flow.
- Initiate, recommend, or provide solutions through designated channels.
Education, Experience and Certification:
- Ability to follow written and oral instructions with minimum supervision.
- Ability to manage projects to a schedule
- Analytical skills to problem solving to reach logical conclusions.
- Effective team player to various challenges and assignments.
- Good communication skill, both verbal and written reports.
- Bachelor's Degree in Biological Sciences or Engineering
- Experience in a medical device or science related field is a plus (or M.S. degree).
Job Type: Full-time
Pay: $1.00 - $2.00 per year
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
- 8 hour shift
- Day shift
- Monday to Friday
Ability to Commute/Relocate:
- Oakland, NJ 07436: Reliably commute or planning to relocate before starting work (Required)