Senior Process Development Engineer

Primary Function

This person is responsible for managing, guiding, tracking, and reporting progress on process development engineering activities as well as working to complete (and help teammates complete) process development engineering related work in a timely manner. This person is accountable for preserving the established design of a product through New Product Development and to transfer to manufacturing.

Essential Job Function/Duties

• Leads core team members on a cross functional project team whose responsibilities are to conduct studies directed toward the development of processes.
• Supports, mentors, and influences core team members on cross functional development projects to ensure timely completion of project deliverables.
• Leverages subject matter expertise (SME) on elements of process development to ensure manufacturing processes are successfully implemented.
• Participates and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes.
• Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods.
• Coordinates or performs validations and documents risk management activities to support regulatory submissions or product launches.
• Promptly understands, evaluates, and communicates technical risks to core team members and management throughout development projects.
• Responsible and accountable for Process Development deliverables required to support both new product development projects and design change projects.
• Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews.
• Gather the facts and communicate them to key stakeholders
• Propose solutions and decisions.
• Understand and demonstrate effective writing skills appropriate for the medical device industry.
• Understand and demonstrate best-practices for presenting information.
• Supports Quality process improvement initiatives using lean manufacturing methodologies.
• Uses highly effective communication and works with minimal supervision.
• Coordinate Engineering resources to ensure projects are completed efficiently and effectively.
• May supervise other Process Development Engineers including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to new product development initiatives.
• Remain current and apply the understanding of relevant regulatory and quality standards/guidance.
• Use and demonstrate competence with root cause analysis methodologies (e.g. 5 whys, fishbone analysis).
• Use and demonstrate competence with continuous improvement tools.
• Maintain training on and constantly work to develop/improve process for process development engineering documentation and execution.
• Seek new skills/knowledge relevant to CBI.

Minimum Work Experience/Educational Requirements

• BS in engineering or related field with at least 10 years of experience, OR M.S. Sc. in engineering or related field with at least 8 years of experience, OR PhD in engineering or related field with at least 6 years of experience in engineering or related field.
• Able to set goals for self and work to achieve milestones.
• Able to work effectively on multiple projects simultaneously
• Able to understand basic statistics and process analysis
• Able to operate statistical software such as JMP or Minitab
• Excellent written, verbal, and organizational skills.
• Experience successfully designing and executing process validations (protocols, reports, testing).
• Excellent record keeping and documentation skills.
• Interest in working directly in a manufacturing environment
• Willing to work with material derived from animal tissues
• Sufficient background to generally understand medical and biotechnology terminology
• Experience effectively mentoring and leading teams on complex projects
• Experience with application of statistical methods (DOE, t-test, ANOVA, confidence limits, tolerance intervals).
• Able to work both independently and as a member of a team.
• Proficient in Microsoft Office Suite (Excel, Word, Project, PowerPoint)

Physical Requirements/Work Environment

• Must be able to perform the essential functions of the job, with or without reasonable accommodations.
• Limited exposure to hazardous chemicals and/or biohazards
• Physical demands are typical of an office environment.
• Willing to perform other corporate duties when required