Job Description

• Own and maintain business processes for development, qualification, validation and transfer of physical test methods for product verification of new products, and transfer of validated methods to company supply chain, Quality, or manufacturing labs at all company sites. The principal engineer must ensure documentation can withstand an audit and pass agency scrutiny.
• Develop and own Standard Operating Procedures for data creation, storage, retention, and audit in accordance with Title 21 CFR Part 11 Compliance for all lab testing and associated 21CFR 820 requirements for device development.
• Rapidly design, develop, qualify, and innovate automated inspection equipment for company primary containers and devices to meet new and unique product requirements.
• Work with Device Technologies to advance state of the art physical methods and other emerging technologies to characterize, evaluate, and release combination products, primary containers, and secondary packaging. The candidate is expected to support input data solutions going into Device Master Records and associated work product with clinical and commercial manufacturing for combination products, primary containers, and secondary packaging.
• Design, develop and execute mechanical testing using phase appropriate controls for the development and qualification of primary container platforms and medical devices to develop specifications.
• Facilitate communication with compay sites and vendors to establish user requirements for the characterization of primary packaging components used in the commercialization of drug products and devices
• Work closely with facilities, maintenance, instrumentation, and electrical systems to ensure laboratory equipment is maintained in compliance with all industry, regulatory, corporate, and regulatory standards. Ensure laboratory compliance for quality audits utilizing internal and external calibration laboratories, vendors and suppliers.
• Advise others on methods of resolving measurement problems. Keep current with information from other industry experts through participation in government and industrial standardization committees and professional societies

• Doctorate degree and 2 years of engineering experience OR
  Master’s degree and 6 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience.
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• Degree in Engineering, MBA or related field
• 8+ years of experience with 3+ years’ experience in leading a highly matrixed physical characterization metrology laboratory in a highly regulated environment
• Experience including managing a lean, high performing technical staff for 3+ years, direct experience in optimization of equipment designs, physical methods, statistical design (Six sigma is highly desired), geometric dimensions and tolerances, kinetic modeling, Solid Works engineering drawing, DOE, and DFM tool sets
• Formal education in project management
• Excellent problem solving, trouble shooting, and communication skills. Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment with rapidly evolving challenges
• Demonstrated competencies skills and proven track record of leading cross-functional projects,
• ability to coach junior engineers, strong team work, excellent interpersonal and communication skills
• Experience with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP, SolidWorks
  

• Test Method development/validation experience, Equipment qualification and implementation
• Experience with regulated industry
• Pharma, Biotech, preferred
• Experience with managing projects and teams
  Masters, PhD degree, Bachelors with minimum 8 years

• No formal engineering training
• No BS degree
• Job jumping - multiple job changes within the year