Regulatory Compliance and Documentation
Author and execute Process Validation Plans, IQ/OQ/PQ protocols, and validation reports.
Maintain PFMEAs, control plans, process flow diagrams, and Requirements Traceability Matrices.
Support Process Change Assessments, risk assessments, and revalidation activities.
Ensure manufacturing processes comply with QMS, regulatory, and audit requirements.
Maintain accurate, audit-ready technical documentation and engineering records.
Collaboration and Cross-Functional Support
Partner with Production, Quality, Product Development, Test Engineering, Automation, Maintenance, Planning, and Facilities teams.
Represent Manufacturing Engineering during design reviews, project reviews, validation reviews, and audits.
Provide technical guidance and training to operators, technicians, and engineering teams.
Support issue resolution across product lifecycle stages from development through production.
Facilitate effective communication between manufacturing operations and development teams.
Innovation and Continuous Improvement
Develop and maintain manufacturing dashboards, analytics, and process-monitoring tools.
Leverage manufacturing data to identify trends, opportunities, and performance gaps.
Drive automation, digitization, and manufacturing systems improvements (MES, eDHR, Power BI, Tableau, etc.).
Evaluate and implement new technologies, tools, and best practices.
Lead continuous improvement initiatives focused on safety, quality, productivity, and cost reduction.
What You Bring
Minimum Qualifications
Senior Process Engineer: Minimum 5 years of manufacturing/process engineering experience.
Bachelor's degree in Industrial Engineering, Mechanical Engineering, Manufacturing Systems Engineering, Biomedical Engineering, or a related engineering discipline.
Experience supporting production lines in a 24/7 manufacturing environment.
Hands-on experience with automated manufacturing equipment and systems.
Proven track record of leading and supporting engineering projects in highly collaborative, cross-functional environments.
Strong knowledge of quality systems, including ISO 13485, FDA regulations, and manufacturing validation practices.
Experience with process validation, including IQ/OQ/PQ, risk assessments, and change management.
Knowledge of manufacturing processes & equipment for high volume production of discrete products.
Excellent communication and documentation skills, including technical reports.
Proficient with CAD software (e.g., SolidWorks) and data analysis/statistical tools (e.g., Minitab, JMP).
Ability and willingness to work a flexible schedule to support project execution, validation activities, and critical production issues.
Perform other duties as assigned to support business, operational, and project objectives.
Preferred Qualifications
Master's degree in an engineering-related field.
Experience in medical device manufacturing and regulated environments.
Knowledge of manufacturing systems, process monitoring systems, and statistical process control.
Six Sigma Green Belt or higher certification.
Experience with manufacturing data analytics platforms such as Power BI, Tableau, MES, or eDHR systems.
Experience supporting automation, equipment commissioning, line transfers, or new product introduction (NPI).
What Sets You Apart
Core Competencies
Strong analytical problem-solving and decision-making skills.
Excellent communication and interpersonal abilities.
Detail-oriented with a strong commitment to quality, compliance, and documentation.
Ability to manage multiple priorities in a fast-paced manufacturing environment.
Strong project management and organizational skills.
Team player with a proactive approach to innovation and continuous improvement.
Ability to influence and collaborate effectively across Operations, Quality, Product Development, Planning, Automation, and Facilities teams.
Why Join ResMed
We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. 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. Employees scheduled to work 30 or more hours per week are eligible for benefits. 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 three weeks 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.
At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range for this position is: $120,000 to $180,000
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
