Manufacturing Engineer

Quasar Medical; Alberta; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading medical device company in Canada is seeking a Manufacturing Engineer to support production processes, focusing on new product introduction and process improvements. The ideal candidate should have a Bachelor's degree in Engineering, 5-8 years of experience in a high-volume production environment, and strong documentation skills. This role will involve ensuring product quality and compliance with various regulatory standards.

Qualifications

• 5 to 8 years’ experience in a high-volume production environment.
• Medical Device Manufacturing experience preferred.
• Ability to write protocols for validations and qualifications.

Responsibilities

• Evaluate and improve manufacturing processes.
• Design and develop manufacturing processes for new products.
• Conduct process qualifications and validations.
• Ensure product and process quality.

Skills

Interpersonal skills

Statistical techniques (SPC)

Documentation management

Process capability definition

Education

Bachelor in Engineering or similar technical field

Tools

CAD software

Job description

Job Summary:

The scope of this role is to support Singapore operations covering scope assigned based on product and site need from new product introduction, new process engineering and sustaining engineering.

The scope of this role is to support the production process, not limit but includes Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore. Develop, improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

The candidate will cover duties and job assignment from product and/or process develop/ transfer/ improve manufacturing processes by evaluating/ assessing product drawings/prints and manufacturing methods in all areas of Quasar Singapore.

Essential Duties and Responsibilities:

• Evaluates/ improves manufacturing processes through designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
• Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
• Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Lead and drive process qualifications and validations including equipment qualification and material specifications.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analysing, and summarizing information and trends.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Maintain and comply with EHS, ISO13485, GMP, FDA regulations and GDP requirements.
• Required to perform rotating shift duties, including evening and night shifts, and may be assigned different roles within the team to support operational needs.
• Any other project or duties as assigned.

• Availability to travel if required.

Education/Experience and Qualifications:

• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques (SPC).
• Knowledgeable in defining process capabilities and control charting.
• Strong and meticulous in documentation and record management. Ability to manage Engineering Change Order.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Proficiency with CAD software is required.

Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives.

• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.