Position Title: Senior Operations Engineer
Position Overview
The Sr. Operations Engineer will provide technical leadership, machine design, and process expertise towards the final stage process development, transfer, scale up, and commercialization of new and existing product lines. They will direct or participate on cross-functional project teams and partner with R&D and/or external manufacturers on the transfer of new products to production and maintenance of established products as required.
Essential Duties and Responsibilities
- Identify and optimize product/process variables required for maximizing product/process performance at prototype, lab/pilot, and full production scale
- Lead evaluation of final product specifications by prototyping products/processes and performing experiments; from lab to production scale
- Liaison between R&D and TELA Bio Manufacturing or external manufacturers on new product lines and current product/process improvements
- Prove product/process performance at prototype, lab/pilot scale, and full production scale
- Collaborate on evaluation of scale up options, selection, & implementation by leading sub projects, providing project updates, and offering input for the next phases
- Evaluate, identify and recommend/implement improvements (productivity, efficiency, reliability) to existing processes or products.
- Design, assemble and test semi-automated and automated tooling required to improve current processes, or needed for new projects/product lines
- Create and/or process change orders, process routers, drawings, and other written documentation in accordance with cGMP requirements to support product development, process development, validations and manufacturing.
- Evaluate potential new product/process proposals and provide recommendations as to the scope and necessary timing required for specific production targets to the scope and necessary timing required for specific launch targets
- Develop project plans, estimating project costs, operating costs, project schedules milestones, and resource requirements.
- Lead improvement of infrastructure and capabilities
- Analyze results of experiments against objectives/targets
- Work with manufacturing team to ensure execution of experiments in a timely manner
- Support Design Verifications, Design & Development reviews, and Verifications & Validations for new product development.
- Conduct investigations into NCRs, CAPAs, customer complaints and resolution as it relates to Operations process, equipment or product requirements.
- Provide in-house development and/or technical leadership to Operations.
Education and Experience
- BS in Mechanical, Packaging, Manufacturing/Industrial or Biomedical Engineering
Required Knowledge, Skills and Abilities
- 5+ years in an engineering function in the Medical Device or Pharmaceutical industry.
- Thorough knowledge of FDA and ISO requirements related to process controls in cleanroom manufacturing and packaging.
- Experience with robust equipment and process verification and validation including IQ/OQ/PQ as part of process qualification.
- In-depth knowledge of medical device sterilization technologies.
- Understanding of design control requirements with experience effectively managing design transfer projects.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to:
- Ability to carry and lift product inventory and equipment of up to 50 lbs.
- Must have demonstrated ability to multitask in high pressure, changing conditions.
Working Conditions
This position works in the Corporate Office, which includes laboratories and manufacturing cleanrooms. The noise level in the work environment is quiet to moderate.
Primary Location and Travel
The role will be staffed at the Corporate Headquarters in Malvern, PA. Occasional travel is required as needed to corporate-based meetings.
Disclaimers
This is a representative description of the job and is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.
TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website: www.telabio.com
