Product Development Engineer

VAUPELL INDUSTRIAL•Constantine, MI

6h•Onsite

About The Position

The role directs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of new product introduction of large-scale programs. These programs will be related to building injection molds, validating injection molding processes following Scientific Injection Molding principles and procurement/validation of part handling and automated assembly equipment for press side and standalone operations.

Requirements

Bachelor’s degree in engineering or related field from an accredited institution or equivalent experience or combination of education and experience.
Five (5) years in a Program Manager role.
Knowledge of SIM for medical validations.
In-depth understanding of part design, tool design, materials, processing, and fixtures.
Knowledge of tool design, hot runner manifolds, valve gate technologies, Mold Flow analysis.
Experience procuring and validating robotics and automation for part handling, assembly, decorating and packaging of medical device components and subassemblies. Following GAMP guidelines for automation validation.
Statistical analysis understanding of capability analysis, process centering with design of experiments and utilizing SPC and real time process controls on injection molded parts.
Competence in applying advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
Ability to read, speak, understand, and follow instructions in English.
Must be able to wear and properly use the required personal protective equipment.
Candidates must be a “US Person” (i.e., US Citizen or Permanent Resident) to ensure Vaupell's compliance with ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations).

Nice To Haves

Design experience related to solid modeling of end of arm tooling or simple automation is desired.
PLC programming and controls engineering knowledge is a plus.

Responsibilities

Provide Design for Manufacturing (DFM) technical support for customers.
Reviews product design for compliance with engineering principles, company standards, and customer contract requirements, and related specifications.
Leads the creation and analysis of DOEs.
Facilitates NDA’s, contracts, customer documentation and forms as needed.
Quoting new parts, re-quoting of existing parts, and preparing quote proposals for customers.
Develop and implement cost reduction ideas and prepare capital expenditure requests that meet company acceptable ROI (Return on Investment).
Adjusts complaints concerning billing or service rendered, referring complaints of service failures to designated departments for investigation.
Assisting in closing out CAPAs on an as needed basis.
Develops key data for customer validation requirements (FMEA, IQ, OQ, PQ, PSW and PPAP submissions).
Communication/Resolution of all issues affecting customer perception including but not limited to Quality, delivery, tool maintenance requirements, price negotiations, logistical needs, payment terms and EDI requirements).
Perform activities as they relate to Quality Systems and Regulatory Requirements such as: ISO 9001:2000; ISO 13485:2003; 21CFR Part 820; AS 9100.
Serve as a project Team Leader providing assigned customers with front-line commercial and technical project engineering support including defining and documenting customer requirements, quoting, prioritizing workflow, and assisting in securing new business development opportunities.
Creates, manages, and maintains schedule, Risk Assessments and Communication Plans for all new product introduction activities at facility.
Provides production solutions that meet regulatory requirements, approach/exceed LEAN capability, and meet cost/delivery targets.
Serving as liaison between Engineering and Operations to review quotes, new business opportunities and to ensure the organization responds to issues in a timely manner.
Managing tool builds and supplying project timelines.
Troubleshoot existing issues from process control and tooling to inspection.
Follow all Vaupell policies and procedures.
Other duties as assigned