Mechanical Engineer

Role details

Job Summary

Plastikon Healthcare is looking for a Mechanical Engineer will be responsible for engineering activities required to launch, commission, and sustain a new production line with primary responsibility for tooling, molds, and injection molding equipment. This role combines hands-on equipment and process development with disciplined documentation, qualification, troubleshooting, and continuous improvement within regulated medical-device environment.

This position will work closely with manufacturing, quality, validation, maintenance, automation, supply chain, and external equipment and tooling partners to establish safe, capable, reliable, and compliant production processes.

Role focus: Translate product and process requirements into robust tooling and molding solutions that support a successful production-line launch and repeatable medical-device manufacturing.

Key Responsibilities

• Own assigned mechanical engineering deliverables from concept development through production-line launch, ramp-up, and sustained operation.
• Define equipment, tooling, mold, fi xture, and process requirements in collaboration with manufacturing and quality stakeholders.
• Develop technical specifi cations, review supplier proposals, support design reviews, and manage engineering changes through approved processes.
• Lead structured troubleshooting using data, direct observation, containment, and documented root-cause analysis.
• Create clear engineering documentation, including specifi cations, trial plans, reports, work instructions, and acceptance records.

Tooling Engineering Responsibilities

• Support mold and tool design for injection-molded medical-device components, including parting lines, gates, runners, cooling, ejection, venting, and tool maintenance access.
• Review mold-flow results, drawings, tolerances, material requirements, and design-for-manufacturability considerations as applicable.
• Plan and execute tooling trials, mold acceptance activities, sampling runs, and corrective actions with internal teams and toolmakers.
• Evaluate molded-part defects such as flash, sink, short shot, warpage, weld lines, burn marks, dimensional drift, and cosmetic variation.
• Maintain tooling documentation, revision history, spare-parts requirements, inspection criteria, and service recommendations.

Injection Molding Machine Responsibilities

• Support selection, installation, setup, and operation of injection molding machines, auxiliaries, robots, dryers, temperature controllers, and material-handling systems.
• Establish and optimize molding parameters, including temperatures, pressures, speeds, screw settings, cooling time, hold time, and cycle time.
• Troubleshoot machine, mold, material, and process interactions while protecting product quality and operator safety. Verify machine capability, alarm settings, recipe controls, changeover requirements, and standardized setup conditions.

Production-Line Launch and Commissioning

• Translate the launch plan into clear mechanical, tooling, equipment, utility, and readiness actions with owners and completion criteria.
• Coordinate equipment installation, utility verification, dry cycles, mold installation, initial trials, material runs, and production-representative testing.
• Identify commissioning issues early, document risks and open items, and drive timely resolution before production release.
• Support operator and technician training, standardized work development, line balancing, and controlled handoff to operations.

Process Development and Optimization

• Develop molding processes that meet product specifications, cycle-time objectives, material requirements, and manufacturing constraints.
• Use designed experiments, capability studies, statistical analysis, and structured problem-solving to establish robust process windows.
• Monitor process trends and variation, identify improvement opportunities, and implement changes through approved change-control procedures.
• Reduce scrap, downtime, variation, and recurring defects while preserving product performance and validated conditions.

Quality, Validation, and Regulatory Responsibilities

• Work within the applicable medical-device quality system, including document control, change control, nonconformance, corrective and preventive action, and training requirements.
• Prepare or contribute to equipment qualification and process validation activities, including user requirements, risk assessments, protocols, execution records, and final reports.
• Support design and process risk-management activities, including identification of failure modes, process controls, and verification of risk mitigations.
• Ensure engineering records, trial results, deviations, acceptance criteria, and equipment settings are complete, accurate, traceable, and audit-ready.
• Participate in internal, customer, and regulatory audits as needed, providing objective evidence for equipment, tooling, and process controls.

Quality expectation: Every process change, tooling adjustment, and equipment decision must be evaluated for product impact, documented appropriately, and implemented through the applicable approved process.

Preventive Maintenance and Reliability Collaboration

• Partner with maintenance and operations to establish preventive-maintenance tasks, inspection points, spare-parts strategies, and equipment care standards.
• Analyze downtime, repeat failures, tooling wear, and machine performance trends to improve equipment reliability and maintainability.
• Support troubleshooting, planned repairs, calibration coordination, and post-maintenance verification for molding equipment and associated systems.

Safety and Compliance

• Design and operate within applicable machine-safety, ergonomic, environmental, material-handling, and workplace-safety requirements.
• Verify that guarding, interlocks, emergency stops, lockout/tagout provisions, and safe operating procedures are addressed before equipment release.
• Stop and escalate unsafe conditions, document hazards, and support corrective actions that protect employees, product, and equipment.

Cross-Functional Collaboration

• Coordinate with manufacturing, quality assurance, quality engineering, validation, automation, facilities, maintenance, supply chain, and contract partners.
• Communicate technical risks, decisions, schedules, and tradeoffs clearly to both technical and non-technical stakeholders.
• Build productive working relationships with molders, toolmakers, machine suppliers, material suppliers, and service providers.

Required Qualifications

• Bachelor’s degree in mechanical engineering, manufacturing engineering, or a closely related discipline, or equivalent relevant technical education and experience.
• Hands-on experience with injection molding equipment, molds, tooling trials, and production-process troubleshooting.
• Working knowledge of mold and tool design principles, injection molding parameters, material behavior, and dimensional or cosmetic defect analysis.
• Demonstrated ability to perform root-cause analysis, process capability studies, and data-based problem-solving.
• Experience creating and maintaining controlled engineering documentation in a quality focused manufacturing environment.
• Ability to work safely around operating machinery, production materials, tooling, and industrial equipment.

Preferred Qualifications

• Experience launching or commissioning a new production line, molding cell, or manufacturing process.
• Experience with equipment qualification, process validation, statistical process control, and risk-management methods used in medical-device manufacturing.
• Familiarity with regulated quality systems and applicable medical-device manufacturing standards and regulations.
• Experience working with robotics, automation, vision systems, hot runners, dryers, temperature controllers, or other molding-cell auxiliaries.
• Experience collaborating with external toolmakers, molders, equipment suppliers, or validation partners.

#PKJOBS

Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Parental leave
• Referral program
• Retirement plan
• Vision insurance

Work Location: In person