Senior Manufacturing Engineer

Resonetics; New Freedom (York County); On-site; USD 110,000 - 124,000; Full time

Job summary

Resonetics in the United States is seeking a Senior Manufacturing/Process Engineer to manage process transitions from validation to manufacturing control. You will lead process improvement, optimization, and development for plastic injection molding programs, applying scientific molding to validate and troubleshoot processes.

You will work closely with customers during onsite validations and project management meetings, coordinating with the site Tool Room and cross-functional teams to deliver

Qualifications

• BS degree in Engineering or Physics required or equivalent.
• 5–10 years manufacturing/process engineering experience.
• Experience with process/product transitions through validation to manufacturing.
• Hands-on with plastic injection molding equipment and troubleshooting.
• Strong project management and cross-functional coordination skills.
• Good communication and ability to meet deadlines.

Responsibilities

• Lead scientific plastic injection molding validation activities.
• Troubleshoot and improve existing validated plastic processes.
• Define preventative and corrective actions.
• Lead customer project management meetings on process validations.
• Coordinate project and manufacturing support assignments.
• Prioritize multiple initiatives and leverage team to deliver results.
• Ensure documentation and compliance with Quality System requirements.

Skills

Process Validation

Project Management

Lean Six Sigma

Statistical Analysis

Communication Skills

Hands-on

Team Collaboration

Education

Bachelor's degree in Engineering or Physics

Tools

Plastic Injection Molding Machine

Mold Tooling

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Senior Manufacturing/Process Engineer will be responsible for managing Process Transitions through Validation to Manufacturing control. This individual will be responsible and manage Process Improvement/Optimization and Process Development for plastic injection molding programs. This role will require the knowledge and use of scientific molding to lead molding validations as well as troubleshoot and improve current validated processes.

This position will work closely with customers through interactions including, but not limited to, onsite validation activities, project management meetings, etc. In addition, this position will work closely with the site Tool Room.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Lead Scientific Plastic Injection Molding Validation activities
• Troubleshoot and improve currently validated plastics processes
• Define preventative and corrective actions
• Lead customer project management meetings regarding the status of process validations
• Perform and coordinate project & manufacturing support assignments
• Supports multiple initiatives concurrently; appropriately prioritizes and leverages team to deliver results
• Contribute to projects with proficiency across most technical dimensions within the functional area; may support cross-business unit/ global initiatives
• Plan and complete requisite supporting documentation, ensuring compliance with industry standards and Quality System requirements
• Lead moderately complex projects and initiatives, serving as business unit resource, providing insight for area of technical specialization
• Assure safety and regulatory compliance by consistently reporting failures / issues to manager and partnering in write up of safety concerns

Required Qualifications

• Minimum BS degree in Engineering or Physics with 5-10 yrs Manufacturing/Process Engineering experience or equivalent
• Experience with Process/Product Transitions through Validation to Manufacturing
• Ability to operate and process a Plastic Injection Molding Machine
• Demonstrated Project Management experience dealing with interdisciplinary interaction to meet project schedules
• Experience with project costing/budgeting
• General understanding of statistical analysis for purposes of equipment validation
• Experienced with Process Improvement/Optimization utilizing Lean Six Sigma (LSS) skillset
• Strong organizational skills
• Hands on
• Excellent communication skills.
• Strongly motivated and goal oriented
• Will adjust working hours and/or work extra hours to meet project deadlines

Preferred Qualifications

• Experience and understand of Mold Tooling
• Experience with Automation Cells in Injection Molding
• Experience with vision systems
• Plastic Injection Molding Certifications (Ex: RJG Master Molder)
• ISO 13485:2003, ISO 9001:2008

Physical Demands

• Must be able to lift up to 25 pounds at times.
• Must have excellent hand-eye coordination.
• Ability to differentiate between colored wires, tabs, and electronic components.
• Must wear gown, gloves, and ear protection if applicable

Compensation

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $110,000–$124,000.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.