Process Development Engineer

• Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
• Designs studies to investigate specific life science questions within field of expertise.
• May be involved in product research and development and/or clinical trials.
• Translates research discoveries into usable and marketable products.

• Typically an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

• Recognized expert, managing large projects or processes.
• Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
• Coaches, reviews and delegates work to lower level specialists.
• Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results .
• May manage large projects or processes that span outside of immediate job area.
• Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation .
• Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
• Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels .
• May negotiate with others to reach understanding or agreement, and influence decisionmaking.
• Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.
• Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• May have broad knowledge of project management.
• Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

• Medical device process development and manufacturing, experience of products with electrical functionality an advantage
• Examples of critical thinking and use of statistics
• Working in a cross functional teams and leveraging basic PM skills e.g. project planning, communication, risk management, etc.
• Work collaboratively and with respect & humility within a cross functional team to establish manufacturing lines for medical devices prioritzing safety, quality service, cost.
• Engage with team to understand goals and current reality, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
• Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
• Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, 6M, timeline, Is/Is not, etc.
• Use statistical techniques to quantify confidence, declare assumptions, be data driven in decision making.
• Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
• Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges
• Ability to work independently, familiarity with common analytical techniques and instrumentation as well as interpretation of data (particularly HPLC, MS, LCMS, FTIR, etc.), data analysis and statistics
• a project leader
• Experience in validation and performance analysis (MSA, IQ/OQ/PQ, TMV) ensuring regulatory compliance and reliability.

• Investigation and root cause analysis skills
• Investigation and root cause analysis skills
• Technical writing knowledge
• Organization and Communication skills
• Process Validation and Computer software validation knowledge
• DFSS Green Belt Certification
• DRM Green Belt certificate
• Experience with DRM / DFSS, Lean Sigma, or Green/Black Belt Lean Sigma certification
• Great Team Worker

Top 3 technical skills that are required for the role:

1. Process development (i.e. process characterization and validation – DOE, PCR, TMV, IQ, OQ, PQ)
2.  Statistics
3. Strong problem solving skills

Education Required: Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering or similar discipline

Years' Experience Required:5 years