Medtronic

Healthcare

Sr.ManufacturingEngineer

$0–0k Kulim, Kedah, Malaysia FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Sr. Manufacturing Engineer at Medtronic. Skills: Manufacturing processes, Process validation, Root cause analysis, Quality control. Support sustaining manufacturing line. Support manufacturing processes”

What You'll Achieve.

Maintain product quality; Maximize equipment utilization; Maximize manufacturing efficiency

Industry & Context.

Healthcare
Problems you'll solve

Root cause analysis; Corrective actions; Troubleshooting

What They're Looking For.

Must Have

Bachelor's degree in engineering or sciences with 4+ years of experience, Master's degree in engineering or sciences with 2+ years of experience

Nice to Have

Master Validation understanding, GD&T knowledge, Risk management experience, FDA 21 CFR Part 820 experience, ISO 13485 experience, Engineering Change management knowledge, PLM tools knowledge, Medical device product development experience, Medical device manufacturing experience, FDA standards knowledge, ICH standards knowledge, IEC standards knowledge, Product lifecycle experience

What You'll Do.

Support sustaining manufacturing line

Support manufacturing processes

Provide daily operations support

Monitor and control processes

Maintain robust processes

Interact with quality

Interact with Regulatory

Interact with Operations

Interact with Marketing

Interact with Supply Management

Ensure manufacturing output

Optimize manufacturing

Investigate manufacturing needs

Oversee shift operations

Maintain continuous production

Resolve documentation issues

Resolve material issues

Resolve equipment issues

Provide updates to management

Escalate issues to management

Author production documents

Maintain production documents

Author equipment qualifications

Maintain equipment qualifications

Author equipment validations

Maintain equipment validations

Investigate equipment non-conformances

Investigate process non-conformances

Investigate product non-conformances

Resolve equipment non-conformances

Resolve process non-conformances

Resolve product non-conformances

Develop innovative solutions

Collaborate with production personnel

Provide training to production teams

Support production teams

Enhance process understanding

Enhance process efficiency

Partner with New Product Introduction teams

Partner with Transfer teams

Execute calibration protocols

Execute process validation protocols

Execute Test Method Validation protocols

Design manufacturing processes

Optimize manufacturing processes

Design manufacturing layouts

Optimize manufacturing layouts

Design manufacturing workflows

Optimize manufacturing workflows

Design equipment installation

Optimize equipment installation

Design material handling

Optimize material handling

Ensure regulatory compliance

Incorporate inspection requirements

Incorporate test requirements

Monitor machinery performance

Improve machinery performance

Initiate corrective actions

Maintain product quality

Apply statistical process control

Provide guidance on design concepts

Maximize equipment utilization

Maximize manufacturing efficiency

How You'll Work.

Team & Collaboration

Cross-functional teams; Production teams; New Product Introduction teams; Transfer teams

Communication Scope

Oral communication; Written communication

Process & Methodology

Project management

Full Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** Medtronic is a 75-year global healthcare technology leader guided by a Mission to alleviate pain, restore health, and extend life — delivering life-transforming technologies across 70+ health conditions in cardiovascular, neuroscience, and surgical care. Today, our 95,000 employees, including 13,500 engineers and scientists, work across 150+ countries, helping treat more than 75 million patients each year. Innovation at Medtronic is disciplined and well-resourced, with $2.7B USD invested annually in R&D, 2,700+ patents, and 174 active clinical trials, all grounded in a deep commitment to quality, ethics, and putting patients first. As our business grows and we expand our operations in Malaysia, we’re looking for individuals excited to join a team, one where purpose meets potential to build careers that change lives. **Responsibilities:** • Support the sustaining manufacturing line to a high scale production. You will support processes as required to provide daily operations support to the manufacturing floor including inputs to monitoring and control to maintain robust processes. • This role will interact with different areas in the organization including quality, R&D, Regulatory, Operations, Marketing, Supply Management etc. • Provide support to the manufacturing processes ensuring output. Support day-to-day activities as manufacturing needs to ensure optimization of manufacturing and/or investigations as needed. • Oversee shift operations to maintain continuous production, resolving documentation, material, and equipment issues promptly. • Act as liaison between production and engineering management, providing updates and escalating issues as needed. • Author and maintain production documents, template

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