Manufacturing Engineer II

Resonetics; Stony Hill (CT); On-site; USD 65,000 - 102,000; Full time

Job summary

Resonetics in the United States is seeking a Manufacturing Engineer III to drive the introduction of new systems for Nitinol Tube/Wire production. You will collaborate with QA and Production to ensure quality, yield, and process validation, including creating flow charts and work instructions.

You will lead continuous improvement, mentor operators, and support machine validation activities while maintaining GMP standards and Lean principles in a fast-paced environment.

Qualifications

• BS or MS in Engineering with 2+ years related experience.
• Proficiency with MS Office (Excel, PowerPoint, Word).
• Proficiency in Windows-based systems (SharePoint, OneDrive).
• Strong mechanical troubleshooting and root cause analysis.
• Excellent written and oral communication skills.
• Fluency in English and ability to read procedures.

Responsibilities

• Take ownership of manufacturing through final stages of production readiness and ensure quality and integrity.
• Develop flow charts, PFMEA's, and Control Plans for products transferring to production.
• Provide technical support for assigned development products on the production floor.
• Communicate effectively with operators and other departments.
• Lead and mentor to foster engineering and safety best practices.
• Apply GMP principles to all processes and promote a lean mindset.
• Introduce and set up manufacturing capacity for Nitinol Tube/Wire.
• Review procedures for compliance and obtain approvals.
• Develop and improve production yields through new process controls.
• Work with manufacturing to promote Lean Principles in design and planning.
• Support machine validation activities for smooth production transition.
• Document tasks: prints, work instructions, specs, studies and reports.
• Troubleshoot issues and implement preventive/corrective actions.
• Determine job cost baselines and assist in training.
• Weekly/monthly reporting of activities and performance attributes.
• Occasional customer liaison; may assume project management.
• Apply statistics (DOE, SPC, Capability Studies) as needed.

Skills

Mechanical troubleshooting

Strong communication

Multitasking

Analytical thinking

Education

BS or MS in Engineering

Tools

MS Office

Windows

SharePoint

OneDrive

SolidWorks

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 Manufacturing Engineer III will be primarily responsible for introducing and establishing new systems and technology to facilitate the Production and Manufacturing of Nitinol Tube/Wire for Resonetics. Systems will pertain to Drawing, Heat Treating, Finishing, and other manufacturing processes. The Manufacturing Engineer will act as a technical liaison between Quality and Production.

This position will concentrate primarily Document creation relating to new Quoted tube products and assistance with production team on the Operation of job routers. Router and Work Instruction generation, participation with quality in customer assistance. Occasionally, will work on establishing and improving efficiencies in the manufacturing of Nitinol Tube/Wire.

Additional areas of focus may include but are not limited to: setup reduction, operator training, statistical process control, tool design or selection, and performance metrics. Other daily responsibilities will include designing continuous improvement plans for current production jobs. An important aspect of this position is the hands-on nature of this role. As productions issues are identified, it will often be the responsibility of this individual to advise and resolve production issues.

Responsibilities

• Take ownership of manufacturing of products as they pass through the final stages of production readiness to ensure that quality awareness and product integrity are maintained into production. Assist with creation of Flow Charts, PFMEA's, and Control Plans for products transferring to production.
• Develop understanding of key factors in Nitinol tube production (e.g. mechanical properties, dimensional control, etc) to become a subject matter expert.
• Provide technical support for assigned development products to insure a smooth progression though the production floor.
• Constructively communicate with operators and other departments.
• Serve as a leader and mentor in order to foster a culture of best Engineering and Safety practices.
• For all work and development, the individual considers and appreciates Good Manufacturing Practices (GMP) as an evident part of all processes. The individual must also be a strong supporter of GMP and make it a personal goal to establish such a mind-set.
• Introduce and set-up manufacturing capacity for Nitinol Tube/Wire manufacturing.
• Review existing process procedures for compliance to the designed process intent. Modify procedures as necessary and obtain approval from required cognizant engineers and change review board.
• Develop and improve Production yields through the identification and implementation of new process controls and determine their effectiveness.
• Work with manufacturing personnel to promote Lean Principles in the design and planning phase of the product.
• Provide technical support for machine validation activities to insure a smooth transition into the production environment.
• Thoroughly document tasks including creation of required prints, work instructions, specifications, and Engineering studies and reports.
• Troubleshoot manufacturing issues and develop a plan to contain, correct, and put preventive/corrective actions in place to reduce the possibility of reoccurrence.
• Determine job cost baselines and initiate cost reduction activities.
• Provide assistance in job setup and process training for operators.
• Weekly/monthly reporting of activities and chosen performance attributes.
• Periodic Customer liaison for quality or continuation of engineering related issues. May assume project manager role for specific customer applications.
• Apply statistical methods such as Design of Experiments, SPC, Capability Studies, etc

Required Qualifications

• BS or MS in Engineering with a minimum (2) years related experience, capable of working in a dynamic, fast paced environment.
• Must be proficient with MS Office (Excel, PowerPoint, Word, etc)
• Must be proficient in computer systems (Windows, Folder directory navigation, SharePoint, OneDrive)
• Must possess solid mechanical troubleshooting abilities. (root cause analysis, Mechanical Diagnosis, Willing & able to interview Operators and technicians about production issues)
• Must demonstrate good oral and written communication skills.
• Strong organizational, analytical, and planning skills with the ability to multi-task
• Must be extremely flexible regarding priority changes.
• Individual must be fluent in speaking, reading and writing English.
• Must have the ability to read, analyze, and interpret procedures and/or safety manuals.

Preferred Qualifications

• Must be a self-starter and able to work effectively with minimal supervision.
• General Metallurgy knowledge and/or knowledge of Nitinol properties and how processing changes these properties
• Experience with wire or tube drawing processes.
• Experience with Process Controls: Control Plan, pFMEA, DOE, MSA, Problem solving, etc.
• Experience working with SolidWorks or equivalent CAD software
• Experience working in ISO-9001/13485 or similar environment.
• Ability to effectively present information and respond to questions from groups of managers.

Physical Demands

• Lift at least 50Lbs
• Reach under/into/Over machines to assess and change out tooling and fixtures

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000 - $102,000/year.

• For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa or TN sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.