Quality Engineer Device Development

SHL Group; Deerfield Beach (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities

Challenging assignments

International team

Professional development opportunities

Job summary

SHL Medical, a world-leading innovator in self-injection devices, seeks a Quality Engineer to uphold design controls and risk management across development programs. You will collaborate with multiple teams to embed Quality by Design and use Quality Engineering tools to align product development with regulatory requirements.

The role emphasizes cross-functional teamwork, process improvements, and active participation in risk-based decision making for medical device development and manufacturing.

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 2+ years of Quality Engineering experience.
• Knowledge of ISO 13485, QSR, ISO 14971, IEC62366, IEC62304.

Responsibilities

• Represent Global Quality Engineering in all Design Controls and Product Development related aspects.
• Support the application of Design Controls (Quality by Design) in projects.
• Promote Advanced Product Quality Planning and ensure compliance with relevant standards.
• Facilitate Product Development and Quality Planning process improvements.
• Support Quality Engineering principles in development and production projects.
• Apply Quality Engineering tools and methodologies to product development per regulations.
• Support risk management activities for medical devices and drug/device combinations.
• Identify and trace CTQs with SMEs.
• Review engineering experiments (DOE) results to guide decisions.
• Ensure all functions adhere to SHL procedures during development and manufacturing.

Skills

Quality engineering experience

Cross-functional collaboration

Team player

Problem solving

Education

Bachelor's degree in science or engineering

Job description

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The position of the Quality Engineer SHL Medical holds responsibility for the effectiveness and quality of product design and process developments ensuring its compliance with applicable regulations. The job holder is directly involved in the establishment and application of efficient design controls and risk management procedures and tools and actively cooperates with multiple departments.

Main Responsibilities

• Represent Global Quality Engineering in all Design Controls and Product Development related aspects
• Support the application of Design Controls (Quality by Design) in projects
• Promote Advanced Product Quality Planning and ensure compliance with relevant standards
• Actively take part in/facilitate Product Development and Quality Planning processes improvement efforts
• Support the application of Quality Engineering principles in a dynamic way to development and production projects
• Utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes
• Applies Quality Engineering tools, techniques and methodologies to product development according to the company’s needs and applicable regulations.
• Support Risk Management activities for medical devices and the device part of drug/device combination products for SHL Medical products are of high quality and directs product development decisions by promoting a Risk-Based approach.
• Support SMEs in the identification and traceability of CTQs
• Support studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction.
• Ensure all functions adhere to SHL procedure’s requirements and standards during all development and manufacturing stages.
• Performs other related duties as assigned.

Skills and Qualification

• Bachelor's degree (or equivalent) in a relevant field, preferably in science or engineering.
• 2+ years Quality Engineering or other relevant experience
• Knowledge of ISO 13485 and QSR, ISO 14971, IEC62366, IEC62304.
• Ability to cooperate in a cross-functional, inter-company and international environment.
• A solution-oriented growth mindset coupled with decision‑making skills.
• Team player and self‑starter.

We Offer

• Competitive compensation package
• Modern working environment with state‑of‑the‑art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit:shl-medical.com