Sr. Product Development Engineer

Arch-Medical-Solutions; Kenosha (WI); On-site; USD 108,000 - 132,000; Full time

Job summary

Arch-Medical-Solutions in Wisconsin is seeking an engineering leader to oversee prototype design, testing, fabrication and assembly with meticulous documentation.

You will leverage CAD tools, validate specs, discuss with customers, and drive cost estimates, BOMs, and schedules while ensuring quality and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or Manufacturing Engineering or equivalent.
• 5–10 years in production management or training.
• Proven track record in medical device design and development.
• Knowledge of ISO 13485 and FDA 21 CFR 820 requirements.

Responsibilities

• Support and participate in design, test, modification, fabrication and assembly of prototypes with detailed documentation.
• Use CAD tools for design work.
• Determine design specifications and perform necessary adjustments and calibrations.
• Investigate and evaluate existing technology and develop new methodologies, materials and products.
• Review customer prints for accuracy of product specifications and discuss with customer as needed.
• Provide cost estimates and time standards for manufacturing operations to meet print specifications.
• Conduct quality checks of documents and reports for accuracy.
• Create accurate manufacturing Bills of Materials to drive manufacturing, quality, purchasing and logistics.
• Collaborate with engineering and other departments to ensure designs are producible.
• Identify improvements to increase efficiency and cost savings.
• Evaluate test results for potential applications and establish performance standards.
• Prepare data to determine if design meets functional and performance specs.
• Ensure projects are completed on time and budgets are met.
• Work with plant leadership to promote safety, quality and teamwork.
• Promote sustainable continuous improvement with frontline staff.

Skills

Leadership

Project management

GD&T

Quality management

Education

Bachelor's degree in Engineering or Manufacturing Engineering

Tools

CAD software

Job description

• Support and participate in the design, test, modification, fabrication and assembly of prototypes, and maintain detailed documentation throughout the development process.
• Utilize drafting tools or computer-aided design (CAD) software for design work.
• Determine design specifications and perform necessary adjustments and calibrations.
• Investigate and evaluate existing technology, and develop and implement new methodologies, materials, processes and products.
• Reviews and checks customer prints for accuracy of product specifications, geometry dimensions and quality standards including verifying and discussing with customer as needed.
• Provides cost estimates and time standards for the manufacturing operations ensuring processes are up-to-date and in line with engineering and production requirements to meet customers’ print specifications.
• Conducts a quality check of all documents and reports, verifying accuracy of data, information, and calculations.
• Creates accurate manufacturing Bills of Materials from parts or assemblies to drive manufacturing, operations, quality, purchasing and logistics for a product.
• Confers with other engineering personnel and prepares design modifications as required to ensure designs can be produced by existing manufacturing or processes or methods.
• Identifies, recommends, and implements improvements and/or modifications in sequence of operations, equipment utilization to increase efficiency and cost savings.
• Evaluates engineering test results for possible application to developments of instrumentation or other uses.
• Compiles and analyzes operational, test, and research data to establish performance standards for newly designed product.
• Implements test programs and analyzes test data and reports to determine if design meets functional and performance specification
• Ensures projects are completed on time.
• Ensures financial budgets are followed and met.
• Works closely with other organizational key leaders/departments to achieve cohesive workflow and desired business results (ex: Quality, Inventory, Engineering, MNTC, etc.).
• Serves as key member of the plant leadership team in promoting safety, quality and teamwork.
• Utilizes a hands-on approach in working with the front-line employees to promote and deploy sustainable continuous improvement activities.
• Other duties as assigned.

Qualifications

• Bachelor's degree (Engineering, Manufacturing Engineering are strongly preferred) or equivalent.
• or five to ten years of experience in production management and/or training.
• or equivalent combination of education and experience.
• Proven track record in medical device design and development.
• Knowledge of emerging trends and the ability to influence best practices within the Medical Device development discipline.
• Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
• Strong leadership and project management skills.

Starting Salary Range: $120,000+ depending on experience.

Equal Opportunity Employer
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