Mechanical / Biomedical Design Engineer (Medical Devices)

Location

Malvern, PA | United States

Job description

Mechanical / Biomedical Design Engineer (Medical Devices)

Location :

Northwestern Philadelphia, PA (Hybrid Available)

Compensation :

Commensurate with experience and is a combination of salary and bonus potential.

Opportunity Summary :

Growing medical device manufacturer known for promoting work life balance and a family oriented work environment has an opening for a Mechanical / Biomedical Design Engineer. responsible for helping with the design efforts to create medical devices and their accessories through Feasibility & Planning, Design & Development, Verification & Validation and Transfer to Manufacturing. This position will work closely with other engineering team members, marketing, sales, operations, and physicians.

Job Duties :

• Lead/Support Product development efforts (project specific) through all phases of design (e.g. feasibility through transfer to manufacturing).
• Create and manage solid models, assemblies, and drawings using SolidWorks and SolidWorks Vault (PDM).
• Establish and implement validation requirements for products, test methods, and manufacturing processes.
• Write design and process validation protocols and reports.
• Plan and write Clinical Assessments and Usability Validations.
• Write Hazard/Risk Analysis (per ISO 14971) and FMEAs (Design and Use).
• Create Bills of Materials. Support their entry into Sage ERP system
• Lead project document control efforts in the entering of documents into the Visual Vault and maintaining solid models not resident in the Visual Vault (e.g. SolidWorks Vault).
• Create and maintain FDA compliant Design History Files (DHF).
• Support quality system compliance with FDA QSR and ISO 13485, and regulatory submissions.

Requirements :

• 4-6 years’ experience in design and development of complex medical devices.
• Must have a minimum B.S. Biomedical or Mechanical Engineering.
• Strong proficiency with developing complex devices in SolidWorks.
• Ability to use hand tools to create prototype/proof of concept devices.
• High degree of initiative and self-motivation with a strong sense of accountability.
• Ability to work effectively in a team environment and build strong working relationships.
• Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence.
• Excellent organizational skills and attention to detail.
• Strong communication skills, both oral and written.
• Ability to prioritize, multi-task and adapt to change.
• Working knowledge of quality systems regulations i.e., FDA QSR, ISO 13485, is required.
• Candidates who have prior experience with manufacturing processes (e.g. CNC machining, injection molding, rapid prototyping) will be given higher considerations.
• This position requires up to 15% travel.

Keywords: Mechanical Design Engineer, Biomedical Design Engineer, Medical Devices, Solidworks, CNC Machining, Injection Molding, Rapid Prototyping, FDA QSR, ISO 13485

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Job tags

Salary