Senior Medical Device Project Engineer

NML Medical; Pennsylvania; On-site; USD 110,000 - 140,000; Full time

Job summary

Globus Medical is seeking a Senior Project Engineer to oversee engineering functions across product lines, from concept to FDA approvals and post-launch monitoring. You will work with spine surgeons and cross-functional teams to ensure quality and on-time product introductions.

Required five years in mechanical design engineering, a mechanical engineering degree, and Creo proficiency. Strong leadership, multitasking, and communication skills are essential to navigate regulatory requirements and

Qualifications

• Minimum five years of mechanical design engineering experience, preferably in the medical device field.
• Bachelor's degree in Mechanical Engineering or similar area of study.
• Proficiency in Creo software for design and drafting.
• Proven leader of people with strong self-starting skills.
• Ability to work in fast paced environment; multi-tasking abilities required for successful job completion.
• Well organized, detail oriented and team player capable of working in a deadline dictated environment.
• Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers.
• Proficient in preparation of reports and budgets.
• Proficient in Microsoft Office.

Responsibilities

• Obtaining market feedback from surgeons and customers to determine functional and design specifications for new product development.
• Creating and maintaining project plans and FDA complaint DHF for each project.
• Managing all aspects of assigned projects to ensure timely completion while complying with quality systems and regulatory bodies.
• Designing and developing instruments and implants using Creo software.
• Partnering with prototype shops and vendors for rapid prototyping and evaluation.
• Performing design verification and validation activities to ensure designs meet specifications.
• Collaborating with marketing and product managers to develop forecasts and market plans.
• Assisting in writing regulatory applications to the FDA and other bodies.
• Partnering with operations to setup manufacturing and/or purchasing for each project.
• Participating in product introductions through training and customer visits.
• Maintaining post introduction monitoring to address customer requests for changes.
• Researching industry and competitors to ensure cutting edge technology.

Skills

Mechanical design engineering

Leadership

multitasking

Attention to detail

Team player

Report writing

Communication

Microsoft Office

Education

Bachelor's degree in Mechanical Engineering

Tools

Creo

Microsoft Office

Job description

Globus Medical is seeking a Senior Project Engineer to oversee engineering functions across product lines, from concept to FDA approvals and post-launch monitoring. You will work with spine surgeons and cross-functional teams to ensure quality and on-time product introductions.

Required five years in mechanical design engineering, a mechanical engineering degree, and Creo proficiency. Strong leadership, multitasking, and communication skills are essential to navigate regulatory requirements and