Senior Manufacturing Engineer

AppleOne Employment Services; Caguas (PR); Sur place; USD 48 000 - 51 000; Plein temps

Résumé du poste

AppleOne Employment Services in Caguas, PR, is seeking a Senior Manufacturing Engineer for a temp-to-hire role in the medical devices sector. The candidate will drive technical initiatives, support production, and promote operational excellence in a regulated setting.

The role requires leadership, cross-functional collaboration, and strong problem-solving to deliver quality, compliant manufacturing improvements and project success.

Qualifications

• Experience leading complex manufacturing projects in regulated environments.
• Strong root-cause analysis and CAPA capabilities.
• Knowledge of Lean, Six Sigma, and process validation.
• Ability to work cross-functionally with Production, Quality, Maintenance, and Ops.
• 6–10 years in manufacturing engineering.

Responsabilités

• Lead moderately to highly complex projects from planning through evaluation.
• Troubleshoot process issues and implement engineering solutions.
• Improve manufacturability, equipment availability, and process performance.
• Develop and maintain manufacturing documentation and validation records.
• Collaborate with cross-functional teams to meet production goals and compliance.
• Analyze data to drive corrective and preventive actions.

Connaissances

Project management

Regulated environment

Root cause analysis

CAPA

Lean Manufacturing

Six Sigma

Cross-functional collaboration

Budgeting & planning

Leadership & communication

Bilingual English/Spanish

Description du poste

Job Summary

We are seeking a Senior Manufacturing Engineer for a temp-to-hire opportunity in Caguas, PR within the medical devices and supplies industry. This role is ideal for an experienced engineering professional who thrives in a regulated manufacturing environment and enjoys improving processes, supporting production, and driving operational excellence. The Senior Manufacturing Engineer will support manufacturing operations, improve product quality, increase equipment availability, and lead technical projects that strengthen production performance. This is a hands-on role working closely with Production, Quality, Maintenance, Operations, and other cross-functional teams to solve complex manufacturing challenges and implement sustainable improvements. This opportunity offers meaningful work in medical device manufacturing, where quality, safety, compliance, and product performance matter. Candidates can expect a collaborative environment with supportive leadership, strong teamwork, and the potential for long-term career stability through a temp-to-hire path.

Key Responsibilities

• Lead moderately to highly complex manufacturing engineering projects with minimal supervision, from planning through implementation and post-project evaluation.
• Support day-to-day manufacturing operations by troubleshooting process issues, identifying root causes, and implementing effective engineering solutions.
• Improve manufacturability, equipment availability, process performance, production readiness, quality, efficiency, and cost effectiveness.
• Develop, update, and maintain manufacturing documentation, including work instructions, process specifications, validation documentation, engineering change records, and process controls.
• Collaborate with Production, Quality, Maintenance, Operations, supervisors, engineers, and operators to support production goals, corrective actions, and regulatory compliance.
• Analyze process data, evaluate trends, and recommend corrective and preventive actions to improve manufacturing performance and product quality.

Compensation and Benefits

• Pay rate: $35 to $37 per hour.
• Job type: Temp-to-hire.
• Location: Caguas, PR.

Required Qualifications and Skills

• Lead complex manufacturing engineering projects in a medical device or regulated production environment.
• Manage project timelines, budgets, resources, implementation plans, performance reviews, and post-project evaluations.
• Drive improvements in manufacturability, equipment availability, production output, quality, efficiency, and regulatory compliance.
• Collaborate with production, quality, operations, maintenance, supervisors, and operators to resolve technical and process-related issues.
• 6 to 10 years of manufacturing engineering experience.
• Experience in medical devices, life sciences, or another regulated manufacturing environment.
• Strong understanding of manufacturing processes, process validation, troubleshooting, continuous improvement, and production support.
• Knowledge of quality systems, documentation control, engineering change controls, process controls, and regulatory compliance expectations in manufacturing.
• Strong ability to analyze technical data, identify root causes, evaluate process performance, and implement practical engineering solutions.
• Experience managing complex technical projects with multiple interdependent elements.
• Strong project management, planning, budgeting, organization, and execution skills.
• Ability to work independently while supporting team-based manufacturing and engineering goals.
• Strong communication, problem-solving, teamwork, and leadership skills in a cross-functional manufacturing environment.
• Ability to serve as a technical subject matter expert and maintain accountability for safety, quality, timelines, and project results.

Preferred Qualifications

• Experience supporting medical device manufacturing operations.
• Familiarity with Lean Manufacturing, Six Sigma, root cause analysis, CAPA, and process validation.
• Experience with equipment qualification, tooling improvements, engineering change controls, production transfer activities, and validation support.
• Demonstrated ability to lead high-impact engineering initiatives from concept through implementation.
• Bilingual communication skills in English and Spanish.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here: https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.