Manufacturing Engineer

Stryker • Fort Lauderdale, FL • 6d ago

As a Manufacturing Engineer at Stryker Robotics, you will play an essential role in sustaining and improving the manufacturing processes of our advanced surgical robotic systems. You will support product quality, process reliability, and operational efficiency while ensuring compliance with Stryker's Quality Management System and regulatory requirements.

Ensure the quality of manufacturing processes and products by adhering to operational specifications and material requirements by managing nonconforming material occurrences.

Participate in the creation and maintenance of PFMEAs, Control Plans, Standard Operating Procedures (SOPs), and Production Part Approval Process (PPAP) documentation to support product transfers and manufacturing scale-ups.

Develop and implement supporting documentation, including work instructions and process SOPs, in alignment with current Good Manufacturing Practices (GMP).

Provide hands-on technical support for troubleshooting manufacturing process and product issues within assigned value streams.

Deliver training to manufacturing team members to enhance process understanding, quality awareness, and operational excellence.

Communicate effectively and collaborate with cross-functional teams and external partners to support system and process troubleshooting activities.

Lead and participate in cross-functional and cross-divisional process improvement initiatives aimed at enhancing productivity, quality, and cost efficiency.

Support process and product validation activities, including Validation Plans (VP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) along with associated documentation.

Conduct Measurement System Analysis (MSA) including Gage R&R studies for new processes and products.

Apply structured problem-solving methodologies to identify root causes and implement corrective actions for NC/CAPA investigations.

Utilize and develop statistical tools to support data-driven decision making and continuous improvement initiatives.

Support capital acquisition projects from equipment specification and supplier engagement to installation, validation, and production readiness.

Minimum Requirements:

Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, Electrical, Robotics, or Manufacturing).

0+ years of experience in manufacturing, engineering, or related technical field, preferably in a regulated industry.

Preferred Skills:

Familiarity with FDA QSR, ISO 13485, and risk-based validation strategies.

Experience in manufacturing process development, troubleshooting, and continuous improvement.

Knowledge of process validation (IQ/OQ/PQ) and measurement system analysis (Gage R&R).

Proficiency in problem-solving methodologies (e.g., Root Cause Analysis, 5 Whys, Fishbone).

Strong communication and collaboration skills to work effectively across teams.

Proficiency in statistical analysis tools such as Minitab or equivalent.

Passion for digitalization: PowerBI

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker

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