Process Engineer

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. The Process Engineer will work closely with the Manufacturing and Quality teams while leading the validation process. 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 qualification

• Drive 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 3rd 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

• ·Strong attention to detail, good oral and written communication skills

• 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.