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.
Let’s talk about Responsibilities
Process Optimization:
- Validate robust manufacturing processes for LSR molding.
- Drive revalidation activities for process/tool/equipment changes in production
- Lead 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:
- Serve as the technical lead in root cause investigations and implementing countermeasures.
- 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.
- Develop and maintain detailed documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs).
- Ensure compliance with electrical and regulatory requirements for North American and European markets.
Let’s talk about Qualifications and Experience
Required 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 automation
- Proven track record in leading and supporting engineering projects in highly collaborative environments
- Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols.
- Proficient in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab, JMP).
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 field
- Familiarity with medical device manufacturing and associated regulatory requirements.
- Knowledge of process monitoring systems (e.g., RJG, Kistler).
- Six Sigma Green Belt or higher certification.
- Strong leadership and project management skills, with a PMP certification preferred.
Core Competencies:
- Analytical problem-solving and decision-making skills.
- Excellent communication and interpersonal abilities.
- Detail-oriented with a strong commitment to quality and compliance.
- Ability to manage multiple priorities in a fast-paced, dynamic environment.
- Team player with a proactive approach to innovation and continuous improvement.
Why Join Us?
At ResMed you will have the opportunity to work on transformative manufacturing technologies in a collaborative and innovative environment. We offer competitive benefits, professional development opportunities, and a chance to contribute to products that improve lives globally.
Equal Opportunity Employer:
ResMed is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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 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.
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 base range for this position is: $79,000 to $119,000.
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.
