Manufacturing Project Lead at Abbott

Minnetonka, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in Electrical, Mechanical, Industrial, Biomedical, or related engineering field
3 years minimum of manufacturing experience within medical devices or regulated industries
Proven experience with MES implementation and validation in a GMP environment
(Preferred) Strong knowledge of FDA, ISO 13485, and 21 CFR Part 11 compliance
(Preferred) Excellent project management and cross-functional collaboration skills

Responsibilities

Define functional and technical requirements for MES implementation aligned with product and process needs
Collaborate with cross-functional teams (Quality, IT, Operations, R&D) to ensure MES supports regulatory compliance and manufacturing best practices
Partner with IT and MES vendors to design workflows, data capture, and reporting capabilities
Support validation activities for MES and ancillary MES equipment and ensure adherence to FDA and ISO standards
Analyze current manufacturing processes and identify opportunities for digitalization and automation through MES
Develop standard work instructions and training materials for MES usage
Lead MES implementation project for new product introduction, including timeline and risk management
Act as primary liaison between manufacturing sites and global business excellence teams
Ensure all MES configurations and processes meet Abbott’s quality system requirements and regulatory guidelines
Maintain accurate documentation for audits and inspections

Skills

Manufacturing Execution System

MES

Project Management

Medical Device Production

Manufacturing Compliance

Electrophysiology

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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