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We are looking for an experienced Development Engineer II, reporting to the Vice President of Engineering. This position is responsible for process development, prototyping, and product manufacturability at Innovize, primarily for the Rotary Converting value stream.  These duties include providing design for manufacturability input for new and existing products, evaluating and selecting robust manufacturing processes and materials, acquiring equipment and tooling, developing and debugging processes, creating product drawings and press diagrams, and executing IQ/OQ/PQ validation protocols and reports.  While working closely with customers, manufacturing, sales, and quality, this individual will lead development projects that meet development goals as well as customer expectations and manufacturing expectations for quality, standard cost, and reproducibility prior to transfer into production.

Duties/Responsibilities include but are not limited to:

• Ensure that a Job Hazard Analysis is completed on all new equipment prior to release for production use.
• Provide lead technical role in ensuring that when new jobs are transferred to production, all necessary equipment, tooling, and processes have been properly developed, validated, and documented to ensure consistent production of high-quality product at or below the quoted cost.
• Understand and apply the technical tools of Lean Six Sigma Manufacturing during development to ensure appropriate considerations were made with regard to Single Minute Exchange of Dies (SMED), quality plans, process capability, cellular layout, Poke Yoke (mistake proofing), and single-unit WIP.
• Promote a scientific approach to process development at Innovize that is based on understanding process input variables, limits testing, process controls, and process capability of the output.
• Provide the lead technical interface with customers, material suppliers, test labs, and consultants for new products in development.
• Understand and comply with GMP and ISO13485 requirements.
• Support the sales team with communicating the value of development runs to customers prior to production.
• Complete other duties as assigned.

Accountabilities: 

• Accountable for meeting the Job Hazard Analysis / Safety goals for new and existing equipment.
• Accountable for meeting the actual-to-estimate cost goals for development jobs.
• Accountable for meeting company on-time delivery goals.
• Accountable for achieving the closing meeting goals for development projects.
• Accountable for meeting specification and test method goals.
• Accountable for meeting the Product Quality goals.
• Accountable for completing Strategy Management tasks within the commit-date.

Training/Education/Experience:

• College or technical school graduate and 3 years rotary converting and automation experience or non-degreed with 10 years progressive rotary converting and automation experience in a press setup and troubleshooting capacity.
• Experience with or ability to learn IQ/OQ/PQ validation activities, preferably for medical products.
• Experience with performance metrics.
• Experience with or ability to learn regulatory requirements like ISO, GMP, CAPA and others.
• Experience with or ability to learn Lean Six Sigma Manufacturing methodology.
• Experience with vision systems a plus.
• Strong problem analysis and implementation skill
• Proficient PC skills.

Competencies/Talents/Personal Attributes:

• Excellent communication skills, written and verbal with ability to lead meetings and effectively present in front of a group and interact professionally with customers.
• Demonstrates initiative and independence:  Proactively seeks new opportunities and exhibits self-confidence, is action oriented and makes things happen, despite apparent roadblocks.
• Demonstrates organization, planning, and follow-through:  Plans, organizes, and schedules efficiently.  Effectively manages multiple projects, establishes contingencies, delivers on promises, and completes the required documentation.
• Strong math skills with ability to understand and apply statistical techniques such as means, standard deviations, control limits, process capability (Cpks), histograms, Gage R&R, and control charting.
• Demonstrates a commitment to understanding medical manufacturing and ISO13485 regulations through active participation in company training as well as through self-education by reviewing ISO13485 regulations, reading related articles, and attending seminars.
• Ability to read blueprints, to understand geometric dimensioning and tolerances, and to sign off drawings as originator or checker.
• Ability to work effectively on computers, to collect data, to create graphs, to create process flow diagrams, to create product drawings, and to create press diagrams and work center drawings.
• Able to challenge existing assumptions using a fact-based scientific approach coupled with hands-on experience and ingenuity to guide teams toward effective solutions to problems.
• Can speak, understand and write English.

Evidence of Success:

• Able to identify examples of personal leadership and technical contributions during successful rotary converting development projects.