AM Careers@SG

Innovation Engineer

Company:

PrinterPrezz SG PTE. LTD.

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Job Description

Working directly with healthcare professionals at point of care centers, Innovation engineers will facilitate the design process of novel medical devices. This direct partnership brings the knowledge of advanced manufacturing to medical providers to serve unmet needs and improve patient care.

Responsibilities
● Design and develop medical devices, implants, and instruments from concept to market launch. Responsibilities will cover all aspects of the design process, including research,
prototyping, laboratory testing, iterating, design for manufacturing, and detailed design of final parts and assemblies.
● Work in a collaborative environment, interacting with cross-functional teams (Product & Project Management, Quality/Regulatory, Operations, and Marketing).
● Develop product requirements and product specifications based on user requirements.
● Create CAD models and engineering drawings.
● Fabricate and test components and assemblies as needed for product development.
● Work with operations and manufacturing engineers to source appropriate vendors to manufacture products and oversee their procedures and workmanship.
● Create manufacturing process instructions, raw material specifications, and qualification/validation protocols and reports.
● Support creation of test protocols/reports, design review reports, risk management reports, and other supporting documents to comply with the design control processes
● Perform verification/validation testing as required.
● Support all technical aspects of the product and instruments.
● Support regulatory and quality requirements in compliance to ISO 13485:2016 and FDA regulations.

●In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485:2016, or ISO14971), the employee has the responsibility to report any
instances to their direct supervisor or above.

Qualifications
● 3+ years in product development for a high-growth, medical device organization whose products are marketed to a medical specialty practice.
● Proficient with CAD software (SolidWorks preferred), geometric dimensioning and tolerancing, and tolerance analyses.
● Experience with analytical tools such as Finite-Element-Analysis is a plus.
● Must understand manufacturing processes including additive manufacturing.
● Experience with 3D printing technologies from print to post-processing
● Experience with design thinking, rapid prototyping, and fabrication/assembly a plus
● Must demonstrate strong written and verbal skills with experience presenting technical information in a small group setting.
● Must work well in a small team and fast-paced environment.
● Have a track record for successful engineering projects through innovative engineering solutions and cost-effective manufacturing, followed by product support and improvement.
● Have a demonstrated ability to communicate effectively in multidisciplinary settings and work well with co-workers, surgeons, clinicians, regulators, and distributor representatives.
● Have a working cross-disciplinary understanding of a medical device business focused on engineering, manufacturing, operations, R&D, clinical and regulatory, and quality assurance.
● Be a proactive person who attacks problems, displaying initiative and perseverance to bring about meaningful change, and to be open and responsive to new ideas.
● Be known as a person who has high integrity, sound character, a tremendous work ethic and the passion to succeed.

 

Additional Information

Job Title:

Innovation Engineer

Educational Requirements:

B.S required in engineering, design or equivalent work experience

Career Level:

Intermediate or Experienced

Work Schedule:

Full-time

Years of Experience:

0-5

Other Requirements:

Education Requirements
● B.S. required in engineering, design or equivalent work experience.
● Must have a strong passion for product and process excellence and customer satisfaction.
● Medical device industry experience is strongly preferred.

Employment type:

Full Time

Location:

North/South/East/West

Job Specialisation:

Projects Management

Industry:

Biomedical / Healthcare