Job Description

LSL Healthcare is a leading national supplier and a certified Minority Business Enterprise (MBE), recognized as a trusted partner in healthcare supply chains. We specialize in customizing medical and surgical kits, procedure trays, and disposable medical equipment. Committed to quality, value, and exceptional customer service, we provide tailored solutions to meet the unique needs of healthcare facilities nationwide.

Role Description

We are seeing a proactive and technically skilled Manufacturing Engineer to support and improve manufacturing processes for medical devices. This role will lead efforts in design transfer, process validation, automation deployment, and cost-effective scaling of manufacturing capabilities. This role will also contribute to project planning, budget management, and compliance activities working closely with cross-functional teams, and suppliers to ensure product quality, operational readiness, and distributor fulfillment

Key Responsibilities

• Develop, validate, and optimize manufacturing processes to ensure quality, repeatability, and scalability.
• Lead process improvement projects for assembly, packaging and labeling, tailored to distributor requirements.
• Support the design, development and implementation of automated and semi-automated equipment for manufacturing processes.
• Oversee and support IQ/OQ/PQ validations conducted
• Collaborate with quality control teams to ensure adherence to quality standards and regulatory requirements
• Drive continuous improvement initiatives through Lean and Kaizen methodologies.
• Partner with Quality and Regulatory to ensure consistent operational excellence across external partners.
• Ensure that manufacturing processes (including packaging and labeling) are suitable for distribution
• Plan, coordinate, and execute manufacturing projects, ensuring timely completion within budgetary constraints
• Develops and supports Standard Operating Procedures/Work Instructions with internal requirements to ensure regulatory and quality compliance.
• Partner with supply chain and finance to track cost saving initiatives, cost- of poor quality, or cost per unit improvements.
• Develop and maintain project plans, schedules and trackers for design transfer, process validation, and automation projects.
• Participate in supplier audits and support CAPA investigations related to outsourced production.
• Ensure manufacturing documentation aligns with FDA (21 CFR Part 13485, and company QMS requirements.

Qualifications

• Proficiency with Microsoft office suite (PowerPoint, Excel, Word, etc.) and Windows
• Analytical mindset with the ability to use data and information to drive decisions
• The ability to communicate internally to all levels of the organization and externally with suppliers
• Candidates are preferred that have experience managing medium sized projects as a Project Manager in Manufacturing (Medical or Non-Medical, but Medical is preferred).
• Strong knowledge of FDA (21 CFR Part 820) ISO 13485, GMP and QMS documentation standards)

Skills & Experience

• Bachelor’s degree in Engineering, Business Administration, Supply Chain, Logistics or related field, or an equivalent level of experience
• 5-7 years of experience in manufacturing or relevant experience
• Demonstrated ability to apply Lean, Kaizen, or Six Sigma methodologies (Certification preferred)
• Bilingual in Spanish and English is a plus

Compensation & Benefits:

The anticipated salary range for this position is $90,000 - $120,000 annually. The actual pay rate will vary based on applicant’s location, education, relevant experience, skills, and education. This role is eligible for bonus and/or performance-based incentives.

LSL Healthcare offers a competitive salary, performance-based incentives, and a comprehensive benefits package, including health insurance, dental, vision, life, short- term and long-term disability, AD&D insurance, and 401(k) savings plan with employer match, paid time off and holiday pay, as well as professional development opportunities.

LSL Healthcare is an equal opportunity employer and prohibits discrimination and harassment of any kind. All applicants will be considered for employment without regards to race, color, religion, age, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. LSL is committed to cultivating a culture of diversity and inclusion promoting teamwork.

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