Manufacturing Engineering

Manufacturing Engineer (Liquid Silicone Rubber Molding)The Manufacturing Engineer (Liquid Silicone Rubber Molding) is a critical role responsible for supporting production lines and manufacturing processes for Liquid Silicone Rubber (LSR) molding operations. This position involves driving execution of molding technologies, improving efficiency, and ensuring compliance with global quality and regulatory standards in the medical device industry. The role will also include collaboration with cross-functional teams, vendors, and management to deliver high-quality products while achieving cost and productivity targets.Validate robust manufacturing processes for LSR molding.Drive revalidation activities for process/tool/equipment changes in productionLead process improvement initiatives to enhance productivity, cycle time, and material utilization.Design experiments and analyze data to optimize process parameters, ensuring consistent product quality.Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks.Project Management:Coordinate with vendors and suppliers for equipment selection, procurement, and commissioning.Provide regular updates to stakeholders, including management, on project status and milestones.Regulatory Compliance and Documentation:Ensure all processes meet ISO 13485 and FDA regulations for medical device manufacturing.Ensure compliance with electrical and regulatory requirements for North American and European markets.Partner with Quality, Manufacturing Engineering, and Production teams to resolve process challenges.Work with Design Engineering to provide feedback on part designs for manufacturability (DFM).Research and integrate emerging technologies in LSR molding to improve efficiency and reduce waste.Lead initiatives for automation, such as robotic part handling and lights-out manufacturing.Qualifications and ExperienceRequired Qualifications:Bachelor's degree in mechanical engineering, Plastics Engineering, Manufacturing Engineering, or a related field.Minimum 3+ years of experience in Manufacturing Engineering (Ideally with Injection Molding/LSR Manufacturing).Experience supporting production lines in 24X7 environments.Hands-on experience with Molding machines and robotic automationProven track record in leading and supporting engineering projects in highly collaborative environmentsStrong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols.Proficient in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Ability and willingness to work a flexible schedule in support of a 24x7 manufacturing environment, including occasional off-shift and weekend.Preferred Qualifications:Master's degree in engineering fieldFamiliarity with medical device manufacturing and associated regulatory requirements.Knowledge of process monitoring systems (e.g., Strong leadership and project management skills, with a PMP certification preferred.Detail-oriented with a strong commitment to quality and compliance.At ResMed you will have the opportunity to work on transformative manufacturing technologies in a collaborative and innovative environment. We celebrate diversity and are committed to creating an inclusive environment for all employees.We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.Individual pay decisions are based on a variety of factors, such as the candidate's geographic work location, relevant qualifications, work experience, and skills.Where a culture driven by excellence helps you not only meet your goals, but also create new ones.