Senior Integration Engineer

Allendale, MI - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position Title: Senior Integration Engineer
Location: Allendale NJ
Employment Type: Full-time On-site

Position Summary / Objectives

The Senior Integration Engineer will be responsible for supporting the implementation of engineering and development activities for new and existing products providing technical oversight and problem-solving capabilities. The ideal candidate has a solid understanding of manufacturing processes can support both strategic and operational objectives of the business and demonstrates a high degree of professionalism and maturity.

Essential Job Functions

Drive product cost improvements using Lean Six Sigma tools and ensure continuous improvement is implemented and sustained.
Plan direct and actively participate with a hands-on approach in documentation data analysis risk analysis etc.
Collaborate with cross-functional departments for effective project execution.
Lead and coach teams through projects and decision-making to accomplish operational plans (e.g. improve yields reduce scrap etc.) and achieve results.
Design manufacturing processes procedures and production layouts for equipment.
Identify project risks and develop mitigation strategies.
Resolve problems encountered that may affect successful project completion.
Support qualification and testing of new equipment required for new product launches.
Comply with company quality policies procedures and practices through appropriate communication training and education.
Identify and record any problems relating to product process and quality systems.
Initiate action to prevent the occurrence of any nonconformities relating to product and process.
Initiate actions to improve product and process flow.
Initiate recommend or provide solutions through designated channels.
Lead development of validation strategy.
Initiate action to correct or prevent the occurrence of any nonconformities relating to product process and quality systems.
Sign Purchase Orders related to Operations.
Review and approve Engineering Change Orders Master Validation Plans Validation Protocols and Batch Records Process Risk Analyses.

Required Skills & Experience:

Excellent organization planning writing verbal communication and presentation skills.
Strong organizational leadership interpersonal skills and team orientation.
Analytical skills and problem-solving ability to reach logical conclusions.
Experience in medical product manufacturing process development and process engineering.
Experience and working knowledge of FDA regulations/ISO standards for medical devices (ISO 13485 & 21 CFR 820).
Experience with biomaterials cleanrooms sterilization and lyophilization a plus.
Proficiency with SolidWorks (or equivalent solid modeling package).
Six Sigma knowledge.
Proficiency with Minitab.
Data-driven decision making.
Root cause investigations.
Demonstrated ability to execute Lean Manufacturing a plus.

Education Experience and Certifications

Bachelors Degree in Mechanical Chemical or Industrial Engineering with a minimum of 7 years of experience in a medical device or science-related field OR
Masters Degree in Mechanical Chemical or Industrial Engineering with a minimum of 5 years of experience in a medical device or science-related field.

Compensation & Benefits

Company performance bonus eligibility.
401(k) plan with company contribution.
Paid time off and holidays.
Medical prescription dental and vision insurance.
Company-paid life and AD&D insurance.
Wellness and Employee Assistance Program (EAP).
Tuition reimbursement.

Position Title: Senior Integration Engineer Location: Allendale NJ Employment Type: Full-time On-site Position Summary / Objectives The Senior Integration Engineer will be responsible for supporting the implementation of engineering and development activities for new and existing products providi...