Development Engineer II - Innovize

Job Description

Title: Development Engineer II

Department: Engineering

Reports To: Vice President of Development Engineering

FLSA Status: Exempt, Full-Time

Starting Salary: $74K+

Exempt + Potential 7% Annual Bonus

Benefits: Full time associates are eligible for benefits the first of the month following 30 days of service.

• • Medical Insurance
    • HDHP, HSA Plan - Employer Contribution of $1,040/yr.
    • High/Low PPO
    • FSA
  • Dental Insurance
  • Vision Insurance
  • Employer Paid Basic Life Insurance
  • Supplemental Life Insurance
  • Employer Paid Short Term Disability
  • Long Term Disability
  • 401(k) 4% Employer Match
  • Paid Time Off (accrued hours, 120/yr.)
  • 9 Paid Holidays
  • EAP Program
  • Fitness Room

Summary: 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.
• With occasional guidance from Quality or Senior Engineering, 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.
• With occasional guidance from Quality or Senior Engineering, follow 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.
• Accountable for meeting Work Habits goals.
• Accountable for meeting New Project goals.
• Accountable for meeting Profit Contribution goals.
• Accountable for meeting Learning and Development goals.
• Accountable for meeting New Tool Success goals.
• Accountable for meeting On-Time Delivery goals.
• Accountable for meeting Product & Service Quality goals.

Training/Education/Experience:

• College graduate in engineering or related field and over 3 years engineering experience in rotary converting and automation, or technical school graduate with over 6 years engineering experience in rotary converting and automation, or non-degreed with over 10 years progressive rotary converting and automation experience in an engineering 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 packaging and vision systems a plus.
• Strong problem analysis and implementation skill
• Proficient PC skills.
• Proficient CAD experience with designing rotary tools and creating part drawings.

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, to create tool 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.

Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains.

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