Product Development Engineer

Vaupell; Constantine Township (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Vaupell seeks an experienced Program Manager to lead new product introductions for large-scale injection molding programs. You will guide cross-functional teams, perform DOEs, manage quotes, and drive cost reduction while ensuring compliance with ISO 9001/13485 and regulatory standards.

The role requires 5+ years in program management, strong knowledge of SIM for medical validations, and expertise in design, tooling, and manufacturing processes.

Qualifications

• Bachelor’s degree in engineering or related field is required.
• 5+ years in a Program Manager role or equivalent.
• Knowledge of SIM for medical validations.
• Understanding of part design, tool design, materials and fixtures.

Responsibilities

• Directs planning, organization and completion of new product introductions for large-scale programs.
• Lead DOEs and analysis; manage quotes and proposals for customers.
• Develop cost reduction ideas and ROI requests; manage CAPAs when needed.
• Ensure compliance with ISO 9001/13485, 21CFR Part 820 and AS 9100.
• Lead cross-functional teams between Engineering and Operations to address issues and opportunities.
• Maintain schedules, risk assessments and communication plans for NPI activities.
• Support validation submissions (FMEA, IQ/OQ, PQ, PSW, PPAP) and LEAN initiatives.

Skills

DFM support

DOE analysis

NDA/contracts

Quoting

Cost reduction

CAPA

FMEA/IQ/OQ/PQ/PSW/PPAP

Quality systems

Project leadership

Scheduling & risk

LEAN

Automation validation

SPC / statistics

PLC programming

English proficiency

Education

Bachelor’s degree in engineering or related field

Tools

SIM for medical validations

Mold Flow analysis

Robotics validation

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Salary Constantine, MI, US

Position Purpose

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.

Essential Duties and responsibilities

• Provide Design for Manufacturing (DFM) technical support for customers including:
• 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 Engineeringand Operations to review quotes,new business opportunities and to ensure the organization responds to issues in a timely manner.
• Managing tool builds andsupplyingproject timelines.
• Troubleshoot existing issues from process control andtoolingto inspection.
• Follow all Vaupell policies and procedures.
• Other duties as assigned

Job Qualifications/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 andvalidatingrobotics 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.
• 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.
• 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)

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes, airborne particles, and vibrations. The noise level in the work environment is usually moderate to occasionally loud.Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

Required physical skills and abilities (see below)

• A = 20% or less of work time
• B= 20 to 60% of work time
• C = 60% or more of work time
• Blank = Not applicable

Standing

B

Bending at waist

A

Walking

B

Reaching below shoulder level

A

C

Reaching above shoulder level

A

A

Grasping

B

Lifting 25 to 50 lbs.

A

B

Lifting over 50 lbs.

A

C

Carrying under 25 lbs.

A

Feeling

B

Carrying 25 to 50 lbs.

A

Eye-Hand coordination

B

Carrying over 50 lbs.

A

Eye-Hand-Foot coordination

A

Pushing under 25 lbs.

A

Hearing, ordinary

C

Pushing 25 to 50 lbs.

A

Hearing, other (explain below)

Pushing over 50 lbs.

A

Seeing – near vision acuity

C

B

Seeing – far vision acuity

C

Climbing ladders

Depth perception

C

A

Kneeling

A

Keyboarding

C

Pulling

A

Turning/twisting

A

Other

Vaupell reserves the right to change, modify or add to theEssential Duties and Responsibilities of any position at any time.

Vaupell is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, belief and spirituality, gender, age, sexual orientation, gender identity or expression, ethnicity/national origin, pregnancy, genetic information, veteran, or disability status.