Manufacturing Design Engineer

At Cloud DX, our mission is simple : We make healthcare better for everyone. As a leader in digital health, we deliver award-winning virtual care and remote patient monitoring solutions that empower patients to manage their conditions from the comfort of their home.

Our innovative technology improves outcomes for patients with chronic conditions, reduces costs for healthcare providers, and transforms care delivery across North America. Since 2014, we’ve been driving innovation and making a meaningful difference in the communities we serve.

Job Description

The Role

We are seeking a Manufacturing Design Engineer to join our R&D team to take responsibility for design for manufacturing and assembly activities for new medical devices. The ideal candidate should have 5+ years’ experience designing consumer and / or medical devices for high volume manufacturing. Experience with ISO regulated quality management systems (9001 and / or 13485) and injection molding technologies would be an advantage.

What You'll Do

Representing and enforcing DFM / A in design reviews and DFMEAs.

Leading PFMEA / Control Plan creation and updates (with supplier participation).

Creation of assembly flow charts or supervision of supplier assembly flow charts creation for manufacturing or rework activities.

Creation of Work Instructions or supervision of supplier Work Instruction creation for manufacturing or rework activities.

Creation of Control Plans or supervision of supplier Control Plan creation for manufacturing or rework activities.

Support the mechanical and industrial design process and lead the transition to manufacturing.

3D CAD design experience with advanced surface modelling

Liaise with the in-house and external manufacturing teams and CMs.

Lead low-volume prototype assembly activities and device testing procedures.

Identification of DFM / A improvements to existing products to include a cost-benefit analysis to allow senior evaluation and approval.

Identification of manufacturing process improvements to existing processes at CM and tiered supplier base to include a cost-benefit analysis to allow senior evaluation and approval.

Supporting the qualification and selection of new suppliers by providing a thorough evaluation of the suppliers’ manufacturing capabilities.

Create Engineering Change Notices (ECN) as related to manufacturing process improvements.

Contribute documentation to the Quality Management System to support ISO 13485 requirements.

Who You Are

Bachelor's degree in mechanical engineering.

Minimum of 5 years' experience as a manufacturing design engineer in a high-volume manufacturing environment.

Expertise in DFM / A and Lean Manufacturing techniques.

Experience of participation in a product development team from inception to manufacturing launch including evidence of the imposition of DFM / A into the design.

Knowledge of the requirements of TS16949 and ISO9000.

Knowledge and execution experience of APQP, PPAP, PFMEA, Control Plans, and Process Flow.

Strong working knowledge of SolidWorks CAD software.

Proven verbal and written communication skills.

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