Senior Engineer, Product Design

Job Description

Position Summary

The Senior Engineer position in the Vascular Access Product Design Engineering team will have opportunity to create impactful solutions for the medical field in which you will collaborate with Product Design Engineers, Systems Engineers, R&D Testing Labs, Marketing, Design Assurance, as well as internal and external Manufacturing teams.

The primary focus of this role will be performing as the lead development engineer for medical device components and products of varying complexity. The role will also lead the design verification of larger scale new product introduction projects in which they will be responsible for both technical oversight as well as some project management. On smaller scale projects they will act as a mentor to Junior Engineers to provide guidance on design, design verification, technical issues, cross functional collaboration, and project management. This role has a need for strong test method development and design verification background. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. Familiarity with Solidworks, or comparable CAD software, is preferable. Familiarity with Minitab or comparable statistic analytical tools is a plus.

Essential Duties & Responsibilities

• Organizes, plans, and executes product development and formal design verification activities for larger scale new product introduction projects. Consults similar activities for other projects of varying scale.
• Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
• Completes risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and identifies and implements risk mitigation.
• Analyzes, evaluates and plans methods for the solution of complex problems. Conducts investigations of considerable complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results. Contributes to strategy. Defines parameters and boundaries for lower-level design activities. Establishes metrics for key aspects of system performance. Requires multi-disciplinary expertise or in-depth knowledge in a single discipline.
• Develops project direction together with management. Accepts the highest level of accountability.
• Responsible for training/mentoring less-experienced engineers in area of expertise including members of the internal engineering team, interns, and/or cooperative students, or co-ops.
• Resolves complex problems within teams, departments, projects, programs and cross-functionally.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively builds consensus. Contributes to IP portfolio growth through regular invention submissions.
• Work on special projects as they arise.
• Performs additional duties as assigned by manager.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

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.
• Has deep knowledge of engineering best practices. Has subject matter expertise on engineering discipline.
• Solidworks (or comparable CAD software) experience preffered.
• Minitab and statistical experience preferred.
• Medical device or experience in a regulated industry preferred.

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.