Process Development Engineer- Level II

• Design, implement, and successfully scale-up automated and semi-automated solutions based upon sound engineering principles

• Lead initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limits.

• Collaborate closely with site and global partners to define, develop and deploy automated processing technologies including equipment, single-use disposables and processes

• Develop user requirements based on process, quality and fitness for use in a GMP manufacturing environment. Work with vendors, suppliers, and internal partners to translate specific requirements into functional and design specifications

• Lead hands-on activities that support process development and process characterization, including drafting procedures, execution of prototype studies, authoring technical reports, and participating on multi-functional risk assessment teams

• Support management in business case analysis for new projects which includes inputs such as current Vs. forecast capacity, standard cost analysis, and ROI.

• Develop automated manufacturing processes by sourcing relevant technology and/or collaborating with automation vendors to design customized medical device manufacturing equipment to improve safety, quality, efficiency and cost within the manufacturing environment

• Keep abreast of meaningful technical trends and developments and incorporates them into appropriate assignments

• Lead the project management of automation development by using visual project management tools (MS Project, critical path analysis, etc.). Define, manage, and communicate project timelines and risks

• Perform Design for Manufacturing DFM, Design of Experiments DOE and design/process Failure Mode and Effects Analysis (DFMEA/PFMEA)

• Collaborate with the Industrialization team for the development of validation protocols as well as its execution and reporting (for installation qualifications, operational qualifications, performance qualifications and process validations).

• Travel to the vendor sites as needed for equipment development, FAT, or to drive project timeliness.

• Collaborate with the Industrialization team and Maintenance Engineering to troubleshoot manufacturing processes/equipment to resolve production or equipment issues.

• Use CAD to design/review/update tooling and fixtures

• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.

• Support the company's continuous improvement efforts by supporting assignments in other areas as required.

• Responsible for enforcing all EHS policies in their span of control
• Other duties as assigned.

• Bachelor's Degree Engineering degree or related experience preferred or

• 5+ Years Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing, clean room environments required

• 3+ Years Medical products GMP manufacturing experience required

• 3+ Years Successful experience of leading multi-functional teams required

• 3+ Years Experience with development programs

• 3+ Years Experience in a variety of robotic weld applications

• 3+ Years Robot and PLC simulation experience

• 3+ Years Experience with field bus networks, serial communication and Ethernet communication

• 3+ Years Exposure to a wide variety of production machinery, industrial sensors, and equipment.

• 3+ Years Excellent communication skills both written and verbal

• 3+ Years Experience in fast-paced iterative design and manufacturing environments

• 3+ Years Experience solving complex problems with little to no supervision on schedule as an individual or as a member of an integrated team

• 3+ Years Ability to think critically, and demonstrated troubleshooting and problem-solving skills

• 3+ Years Excellent interpersonal, verbal and written communication skills

• 3+ Years Ability to function efficiently and independently in a fast-changing environment

• 3+ Years Self-motivated and willing to accept temporary responsibilities outside of initial job description

• 5+ Years Design, simulate (prototyping), and implement a fully automated controls architecture to build high volume products

• 5+ Years Utilize mechanical automation equipment, robots, PLCs, motion controls, and 3D vision to create entire assembly lines

• 5+ Years Influence the product design in order to simplify and optimize the factory process

• 3+ Years Implement reliable safety systems (ANSI / RIA15.06, OSHA) for safeguarding robots, gantries, conveyors and other high volume manufacturing equipment

• Ability to handle and reason through complex information, define problems, collect data, establish facts, and draw objective conclusions. (High proficiency)

• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. (High proficiency)

• Able to leverage project management & technical experience to foresight potential problems and develop contingency plans to ensure swift recovery in case of adversity. (High proficiency)

• Must be able to deconstruct a problem effectively in order to find the best and fastest solution. (High proficiency)

• Must be able to reason and communicate clearly under pressure. Fast learner and adaptable to medical device processes and regulations. (High proficiency)

• Lean Six Sigma Certification-IASSC preferred

• Candidate must be able to support occasional extended work hours to lead equipment troubleshooting/repairs when needed. Weekend or after-hours on-call support to ensure equipment is operational to support production plans. - Occasionally

• 20% Ability to travel domestic

DiaSorin