Principle R&D Engineering Lead

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS : DO NOT CONTACT.

Job Summary

The Engineer will be a key contributor to the design and development of a therapeutic medical device, from concept to early human use to commercialization. The Engineering Lead will work closely with the team to drive all aspects of the development process including conceptualizing, prototyping, analysis (physical and simulation), researching manufacturing techniques, go-to-market implementation, and manufacturing support.

The ideal candidate will possess some knowledge of balloon catheters (i.e., PTA, PTCA).

Responsibilities :

• Utilize research and experience to develop new product and processes to increase performance.
• Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives.
• Collaborate with external suppliers for component and process design and identify outsourcing opportunities.
• Provide technical leadership and maintain the engineering staff’s knowledge on technology and engineering areas associated with instrument and mechanism design and manufacturing processes.
• Understand the technology and key product features that ensure clinical and commercial success
• Manage research and development activities from Concept Phase through Commercialization
• Make data driven decisions using appropriate analytical methodologies
• Prepare for and conduct various design reviews in accordance with product development
• Demonstrate deep insight regarding design intent and uses insight to drive product requirements and specifications. Develop processes necessary to fabricate devices. Develop and implement test methods for assessing the quality of in-process and finished products.
• Develop, execute, and analyze design verification and validation studies, culminating in a design history file.
• Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
• Provide technical leadership along with technical subject matter expertise to product development team.
• Conduct preclinical build operations as necessary.
• Initiate, define, perform and execute verification and validation activities.
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.
• Perform risk analysis activities and develop product testing plans and protocols; set up and run product testing and protocols in accordance with project plans
• Research and recommend vendor and material choices for product
• Identify hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Comply and analyzes data, identifies causes, draws conclusions, generates reports.
• Create and managing a schedule of technical deliverables in coordination with a project manager.
• Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.
• Identify hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Comply and analyzes data, identifies causes, draws conclusions, generates reports.
• Create and managing a schedule of technical deliverables in coordination with a project manager.
• Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.

Qualifications : Education :

Required Experience :

Knowledge, Skills, and Abilities :