Position Summary

The Senior Engineer position in the Vascular Access Product Engineering group is responsible for managing the post launch life cycle for products that have been released for sale. This includes analyzing change requests and implementing a change management plan, investigating and correcting non-conforming events, including Corrective Actions and Preventative Actions, remediating design history files to conform to new regulatory requirements, and developing line additions to expand the scope of a product portfolio. The Senior Engineer works on projects/matters of advanced complexity with cross functional support and often works independently of managerial staff.

Essential Duties & Responsibilities

• Organizes, plans, and executes activities related to implementing design changes per change management plans and company procedures.
• Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
• Updates design output documents such as engineering drawings, purchasing specifications, and bill of materials.
• Completes risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and identifies and implements risk mitigation.
• Provides technical support to regulatory, sales, marketing and other functional areas as needed.
• Helps lead investigations of root causes leading to non-compliance events arising from design, manufacturing, procedural or customer use.
• Provides technical support as a Subject Matter Expert for a particular Product Family
• Works on special projects as assigned.
Mentors junior members of the engineering staff including interns and/or cooperative students, or co-ops

Knowledge & Skills

• Able to solve technical problems using engineering principles and analytical ability using advanced methodologies, creativity and best practices.
• Able to critically review and interpret technical documentation such as engineering drawings and component specifications.
• Able to work accurately with attention to detail.
• Able to handle multiple priorities and meet key deadlines under pressure through effective time management skills.
• Able to communicate professionally to technical and non-technical internal and external customers, including executive management, through conversations, presentations, and formal and informal electronic media.
• Able to build consensus across project or engineering teams with well-reasoned arguments in a collaborative effort to resolve conflicts or to develop new strategies.
• Able to act as a subject matter expert in a product and/or technical area and have broad knowledge in related areas of expertise.
Able to provide technical input into strategic business decisions and use commercial awareness to make key technical decisions.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor’s degree in mechanical or biomedical engineering from an accredited college or university is required.
Minimum of seven years of work-related experience

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office and laboratory equipment. Work from a home office may be allowed on a limited basis.
• As part of the scope of employment, the employee must hold a valid driver’s license as well as comply and meet the requirements set forth in the Authorized Driver Policy to drive on behalf of the company.
• Typically requires travel 5%-20% of the time.