Mechanical Engineer

As a Mechanical Engineer within the Sleep Product Lifecycle Engineering (PLE) team, you will provide technical ownership and mechanical engineering support for released Sleep Care devices and accessories throughout their lifecycle. The team is responsible for sustaining products already in market, ensuring they continue to meet quality, reliability, manufacturability, compliance, and customer requirements. Typical activities include investigating product and manufacturing issues, implementing engineering changes, supporting supplier and component changes, conducting technical assessments, and driving product improvements. You will work closely with cross-regional functional teams to resolve issues, improve product performance, and maintain long-term product continuity.

Responsibilities

Support released Sleep Care products throughout their lifecycle; Lead or support product, supplier, material, and manufacturing changes; Investigate product, manufacturing, supplier, and field issues; Assess engineering changes for impact to quality, reliability, manufacturability, and compliance; Develop and maintain CAD, drawings, specifications, BOMs, and engineering documentation; Perform verification activities for sustaining changes; Support CAPA, non-conformance, and product improvement activities; Collaborate with cross-functional teams and suppliers; Drive reliability, manufacturability, and cost improvements; Clearly communicate technical recommendations and decisions

Requirements

Bachelor's degree in Mechanical Engineering or an equivalent engineering discipline; 3 – 5 + years of relevant mechanical engineering experience, preferably including product sustaining, manufacturing support, product development or released-product engineering; Strong mechanical design fundamentals and high-volume manufacturing knowledge and processes, including part design, tolerance analysis, material selection, injection molding, polymers and design for manufacturability; Experience working with engineering drawings, CAD models, specifications, BOMs, engineering changes, and technical documentation; Proficiency in 3D CAD modelling, preferably Creo / Pro Engineer or equivalent CAD software; Ability to investigate technical issues using logical, structured, and methodical problem-solving methods; Ability to perform engineering impact assessments and develop technically sound recommendations based on available evidence; Strong written and verbal communication skills, with the ability to document technical decisions clearly and concisely; Ability to work effectively in cross-functional teams and manage multiple priorities in a dynamic environment

Nice to have

Experience in the medical device industry or another regulated industry; Experience supporting released products in a Product Lifecycle Engineering, sustaining engineering, manufacturing engineering, quality engineering, or product support environment; Familiarity with engineering change control, design controls, risk management, verification and validation, and post-market product support; Understanding of quality management systems and applicable standards, including ISO 13485, ISO 14971, and Good Documentation Practices (GDP); Experience supporting internal, supplier, customer, or regulatory audits; Experience with supplier change qualification, alternate component or material qualification, manufacturing transfer, and supply continuity projects; Practical understanding of how mechanical design decisions affect manufacturability, reliability, serviceability, cost, quality, and product continuity