New Product Design & Development Quality Engineer(Parkmore Galway)

Integer; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

Integer in Galway seeks a New Product Design & Development Quality Engineer to lead quality assurance, control and preventive activities across the product lifecycle. You will guide NPI initiatives, cooperate with cross-functional teams and ensure compliance with medical device standards.

This role involves developing test strategies, supporting risk assessments, and mentoring engineers to drive continuous improvement and successful product launches.

Qualifications

• Degree in Engineering/Science (1-3 years’ experience).
• Knowledge of ISO 13485:2016 and medical device manufacturing.

Responsibilities

• Provide quality engineering support for new product introduction, design transfer and product release.
• Support the implementation and improvement of NPI processes and Lean Product Development practices.
• Develop and review test strategies, protocols, reports and verification and validation documentation.
• Support risk assessments and product lifecycle change management.
• Support validation activities throughout the product realization process.
• Ensure quality requirements are addressed across development and manufacturing.
• Collaborate with project teams and customers to resolve quality issues and deliver projects that meet or exceed expectations.
• Apply structured problem-solving and risk-based approaches to investigate issues and implement corrective actions.
• Provide technical guidance, coaching and mentoring to engineers and technicians.
• Collaborate with cross-functional teams to support successful product launches and manufacturing releases.

Skills

Quality engineering

NPI processes

Risk management

Mentoring

Cross-functional teamwork

Education

Bachelor's degree in Engineering or Science

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Job Summary

The New Product Design & Development Quality Engineer will provide quality leadership, direction and technical guidance in quality assurance, quality control and preventive activities with a focus on preventive measures and continuous improvement of products and processes. Lead and strategize initiatives & projects to enhance quality performance within the business. Work with internal customers in support of quality issues and provide technical support for activities related to quality and performance evaluation. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

Essential Job Duties And Responsibilities

• Employees are expected to support the quality concepts inherent in the business philosophies of Integer including a variety of job-related tasks, which may not be specific to this position profile.
• Provide quality engineering support throughout new product introduction, design transfer and product release activities.
• Support the implementation and improvement of NPI processes and Lean Product Development practices.
• Develop and review test strategies, protocols, reports and verification and validation (VV) documentation.
• Support risk assessments and product lifecycle change management.
• Support validation activities, throughout the product realisation process.
• Ensure quality requirements are appropriately addressed throughout product development and manufacturing. Identify opportunities to improve product & process quality.
• Work closely with project teams and customers to resolve quality issues and deliver projects that meet or exceed expectations.
• Apply structured problem-solving and risk-based approaches to investigate issues and implement effective corrective and preventive actions.
• Provide technical guidance, coaching and mentoring to engineers and technicians.
• Collaborate with cross-functional teams to support successful product launches, process improvements and manufacturing release activities.

Skills And Knowledge

• Knowledge of manufacturing operations, systems and project management, including procurement, inventory control, quality control, production planning and control, test and inspection, layout.
• Knowledge of engineering theories, methods and work measurement techniques.
• Ability to apply engineering methods in the definition, design, research, development, utilization, maintenance, and cost-control of processes and equipment.

Minimum Education And Experience Requirements

• Degree in Engineering/Science, with 1-3 years’ experience.
• Working knowledge if IS013485:2016 and medical device manufacturing.

PHYSICAL DEMANDS.

• Work effectively with close tolerance parts & equipment.

MENTAL DEMANDS.

• Ability to work in an organized fashion in a challenging environment of competing priorities.
• Excellent attention to detail.
• Self-starter.

Working Conditions

Day-shift operation, but may be required to change working hours or work other shift patterns occasionally as project responsibility dictates.

REPORTING RELATIONSHIP AND PRESENCE OR SUPERVISOR.

This position reports directly to the Regulatory Affairs and Design Assurance Manager OUS

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U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.