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SHL Medical · 6 hours ago

Process Engineer 1

Deerfield Beach, FL

Full-time

Onsite

New Grad, Entry Level

0+ years exp

SHL Medical is a world-leading solution provider in drug delivery systems, serving top pharmaceutical and biotech companies. The Process Engineer will support the implementation of new process systems into manufacturing production and ensure compliance with quality system requirements while collaborating between development and manufacturing sites.

ManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Support design transfer, specifically the final assembly, labeling, packaging, and serialization of products as they hand-off from development to commercial launch

Support the design, qualification, and implementation of new production equipment

Draft and update Engineering Protocols (ENP) and Reports (ENR), Batch Records (BR), Bill of Materials (BOM), Technical Specifications (TS), Product Specifications (PS), Quality Work Instructions (QWI), Quality Operating Procedures (QOP), Quality Forms (QF), Templates (TEM), equipment design and qualification documentation (e.g., URS), pFMEAs, Change Controls, etc

Draft documentation for computerized system validation (CSV) including Functional/Design Specifications, Design Qualification (DQ), Functional Risk Assessment (FRA), Requirements Traceability Matrix (RTM), etc

Draft and execute Validation Project Plans (VPP), Validation Final Reports (VFR), and periodic reviews, as well as protocols and reports for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, Installation Operational Qualification (IOQ), Performance Qualification (PQ), and Process Validation (PV)

Document MS activities to support the MS Key Performance Indicators (KPI) tracking

Perform troubleshooting and root cause analysis with a cross-functional team to conduct investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc

Serve as the second line of support after Manufacturing Engineering (ME) to Manufacturing (MFG)

Provide training on production equipment to ME and MFG personnel

Identify opportunities for continuous improvement in MS and support the execution and implementation of LEAN projects

Support and conduct customer complaint investigations

Support or lead machine shop activities

Comply with all quality, safety, and industry regulations

Qualification

Biomedical EngineeringMechanical EngineeringFDA guidelinesISO standardsLaboratory PracticeManufacturing PracticesMechanical design principlesMicrosoft ExcelMicrosoft WordDocumentation PracticesEffective communicationCollaboration

Required

Familiarity with industry practices and guidelines including those outlined by the FDA and ISO is required

Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is required

Must have practical experience and a solid understanding of mechanical design principles, testing, and manufacturing processes

Proficiency in Microsoft Excel and Microsoft Word is required

Effective communication (written and verbal) and collaboration within cross-functional teams are required

Preferred

B.S. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study is preferred

0-2 years of experience within the medical device industry is preferred

Benefits

Competitive compensation package

Modern working environment with state-of-the-art facilities and technologies

Challenging assignments in a fast-growing and innovative industry

Position in a dynamic, international team of highly skilled professionals

Various opportunities for personal and professional development within a global organization

Company

SHL Medical

SHL designer, developer, and manufacturer of advanced drug delivery devices such as autoinjectors, pen injectors, and inhaler systems.

Founded in 1989

Zug, Zug, CHE

5001-10000 employees

https://www.shl-medical.com/

H1B Sponsorship

SHL Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)