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Process Engineer - Parsippany, United States - ONKOS SURGICAL
Description
This role is responsible for mid- and late-stage process development and manufacturing scale-up of an implant coating technology using scientific, engineering and manufacturing principles.
This role also requires developing and supporting quality systems related to the coating process, conducting process remediation exercises when necessary, and working with Product Development on design for manufacturability and inspection requirements.
Finally, this role will support new product research and development efforts and associated pre-clinical testing critical for regulatory clearances.Responsibilities
Ensure work output is compliant with all current regulatory and quality standards.
Complete all required training in timely fashion
Work with multidisciplinary project teams and outside suppliers to facilitate the launch of safe and effective products as follows:
Lead the coating process development, scale-up and process validation efforts (including operational and process qualifications) with a focus on the wet chemistry aspects of the process.
Participate in defining equipment specifications, ordering, installation, and qualificationDrive process improvements
Conduct Designs of Experiment
Perform statistical process analysis
Oversee all process validation (IQ, OQ, PQ)
Perform design verification testing
Interface with the contract manufacturer and third-party vendors
Create and manage chemical and process specifications
Document and assess risk analysis via FMEA
Generate process quality requirements
Perform other tasks as project needs dictate
Assist in preparing comprehensive project timelines with technical objectives and milestones (timing, resource requirements, costs, etc.)
Assist Manufacturing Engineers in developing innovative manufacturing and processing techniques and/or seek out new technologies for materials and processing through 3 rd
party relationships
Requirements
A minimum of 5 years of experience in chemical process manufacturing in the medical device field (preferably orthopedic) or pharmaceutical field
Experience with organic chemistry preferred
Minimum of MS degree in Organic (preferred), or Inorganic Chemistry, or alternatively Chemical Engineering
Ability to apply analytical skills in solving chemical engineering problems and developing new technologies
Demonstrated knowledge of statistically driven Designs of Experiment
Demonstrated knowledge of process scale-up and process validations
Demonstrated computer skills including spreadsheets, word processing, database and other applicable software programs
Excellent interpersonal skills; self-motivated
Travel requirement:
Up to 30%
About Onkos
At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.
At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.
At Onkos Surgical, we will:
Find solutions to our patients' unmet clinical needs and advocate for their cause.
Partner with surgical oncologists through research, education, and innovation, to treat their patients more effectively and more efficiently.
Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
Deliver value to our customers and shareholders.#J-18808-Ljbffr