Product Development Engineer

Roles & Responsibilities

Process Development:

· Develop and optimize robust manufacturing processes to achieve quality, cost, and efficiency targets.

· Implement process improvements and control mechanisms to enhance production stability.

Project Management:

· Manage multiple projects simultaneously, focusing on productivity improvements.

· Utilize project management tools to track project performance, timelines, and budgets.

· Identify risks and implement mitigation strategies to ensure timely deliverables.

Automation Development:

· Lead initiatives in automation to streamline production processes and reduce manual intervention.

· Evaluate new technologies and automation tools, making recommendations for system enhancements.

Documentation and Reporting:

· Prepare comprehensive project documentation, including progress reports, proposals, and post-project evaluations.

· Maintain robust documentation practices to comply with industry standards and regulatory requirements.

In-house process capability or continuous improvement projects:

· Maintain working knowledge of quality and medical device requirements, including ISO13485, ISO14971, GMP and other standards as they relate to the design and manufacture of medical devices.

Managing stakeholders

· Interface with customers, inter departments and inter sites technical supports.

· Demonstrated soft skills to manage and positively contribute to complex teams with people from various backgrounds and disciplines.

KNOWLEDGE, SKILLS, ATTITUDES

Knowledge:

. Knowledge of IQ, PQ and validation processes for medical devices is an advantage.

. Knowledge of any statistical software such as Minitab for data analysis and interpretation

. Knowledge of troubleshooting, failure analysis, root cause analysis, issues closure and corrective action processes as required

. Proficient in engineering tools such as statistical analysis, design of experiments, product, and process capability analysis.

· Knowledge of machine troubleshooting and diagnosis is a plus.

Skills:

· Communication and presentation skills

· Project management skills

· Hands on experience needed in the test method design and process verification activities.

· Proficient in Microsoft Office.

. Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.

Attitudes:

· High level of initiatives and creativity

· Excellent analytical and problem-solving skills.

· Strong leadership capabilities with the ability to manage cross-functional teams.

· Effective communication skills, both written and oral.

· Ability to work independently and adapt to rapidly changing environments.

. Ability to work extra hours during critical project phases.

QUALIFICATIONS

• Bachelor’s degree in engineering or a related technical field.
• Minimum 3-5 years of relevant working experience in a manufacturing environment in medical devices or equivalent environment.
• Strong understanding of manufacturing processes and mechanical system design.
• Familiar with Lean manufacturing techniques, and techniques such as FMEA, SPC and DOE methodologies.
• Familiar with ERP system and ISO 13485 requirements.
• Experience with CAD software such as SolidWorks for design of mechanical fixtures and tooling for the production equipment and project management tools such as MS Project or any for project planning and tracking.
• Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint) is required.