Title:  Senior Controls Engineer, Manufacturing Process

QUALIFICATIONS

Required:

• Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university.
• 6+ years of manufacturing engineering experience; OR master’s degree plus 4 years’ experience.

Preferred:

• Experience in medical device or similar regulated industry preferred.
• Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual, cycle time < 3 second.
• Experience capital automation procurement project management
• Experience with automated test equipment development
• Experience with software validation

Skills & Competencies:

• Strong demonstrated ability to execute manufacturing engineering deliverables on time.
• Strong knowledge in medical device manufacturing assembly and test methods.
• Proficiency in reading and understanding industrial controls, e.g. PLC ladder logic (Allen Bradley Compactlogix), HMI (Ignition), and data collection databases (MS SQL). 
• Competent with Solid Modeling (preferable SolidWorks), spreadsheet and statistical analysis software (e.g. Minitab) packages.
• Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
• Familiar with medical device equipment qualification, computer system validation, and process validation requirements to meet FDA requirements 21 CFR 820, and 21 CFR 11.
• Ability to perform equipment troubleshooting (mechanical and electrical).
• Strong analytical and creative problem-solving skills.
• Familiarity in project management fundamentals and best practices, and associate programs (e.g., Microsoft Project), and calibration principles.
• Excellent verbal communication and technical writing skills.
• Ability to collaborate with internal and external cross functional teams.
• Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
• Demonstrated technical coaching and leadership of peers.

Physical Requirements:

• Must be able to work at a desk or remain stationary for extended periods of time
• Must be able to access and navigate all areas of the facility, including clean rooms
• Ability to operate a computer and other office equipment, such as printer, telephone, etc. 

RESPONSIBILITIES

• Perform equipment design, modification, and troubleshooting activities for both new and sustaining programs.
• Develop electrical, mechanical, pneumatic and controls solutions for automation equipment design.
• Perform varied process engineering assignments requiring a familiarity with a range of complex process engineering problems that result in effective process solutions.
• Applies defined standard process engineering techniques, procedures, and criteria, using judgment in recommending minor adaptations and modifications.
• Conduct independent studies and analyses that include interpretations, conclusions and recommendations.
• Assignments requiring knowledge of principles and techniques commonly employed and include the following:
  • Equipment design including PLC programming (Allan Bradley preferred)
  • Preparation of process specifications/datasheets
  • Research investigations & report preparation
  • Provides technical advice (process) to engineers from other disciplines.
• Leading the design of new equipment, from concept/prototyping, 3D modeling, to fabrication/assembly/programming through final validation testing.
• Broad use and application of electrical engineering and controls principles, concepts, theories and techniques to solve problems related to equipment design.
• Procurement of new equipment and strong collaboration with automation suppliers.
• Technical guidance and leadership of engineers in equipment design.
• Ensuring accurate and controlled documents are generated. Produces associated engineering documentation with MS Word, MS Excel and MS Power Point.
• Designing and conducting experiments to validate equipment and processes
• Interacting with Product Development Engineers and manufacturing personnel to ensure product and process are designed for ease of manufacturing.
• Ensure the proper engineering deliverables are generated.
• Work with functional managers and partners to ensure project goals are met.
• Provide technical guidance and coaching of other engineers.
• Contribute to a dynamic start-up environment.
• Contributes to project planning and execution to meet schedule and budget requirements.