Job Description
Job Description
POSITION SUMMARY:
The position is also responsible for interfacing with Senior Management to present product development project status
information, advise on departmental resource needs, and assist in construction of departmental budgets. The MDE is
responsible for directing the initiation, development, and maintenance of design engineering project plans and will have
full familiarity with all Exsurco products and the environments in which they are used.
The MDE is to initiate work assignments and manage projects to completion according to priorities set by Senior
Management. The MDE may complete assignments on their own, or lead others in the completion of assignments, but
retains responsibility and accountability for meeting established objectives. The MDE is to mentor and educate other
members of the Exsurco engineering staff.
KEY RESPONSIBILITIES:
The duties & responsibilities of the MDE include, but are not necessarily limited to the following:
- New Product Development and Product Support
- Lead the end-to-end design and development of medical devices, including conceptualization, prototyping,
testing, and production readiness. - Collaborate with cross-functional teams (Regulatory, Quality, Manufacturing, Clinical) to ensure designs meet
clinical needs, user requirements, and regulatory standards. - Develop and maintain detailed design documentation, including risk analysis (FMEA), design verification &
validation plans, and technical reports. - Creates and/or approves risk assessments of new products.
- Evaluates statutory and regulatory requirements for new products and participates in compliance activities.
- Creates comprehensive test programs and directs execution of laboratory tests as required.
- Estimates timelines and material costs on projects.
- Prepares project schedules for the engineering stages of product development.
- Leads and monitors engineering projects and ensures schedules and budgets are met.
- Assists in the creation of technical manuals.
- Assists sourcing/purchasing functions in the process of supplier selection and approvals.
- Provides technical support as required all other company departments.
- Coordinates initiation, reviews, and approves product-oriented change notices to modify and improve the
configuration of release products. - Evaluates product-oriented change requests from other departments and initiates appropriate actions when
needed.
Intellectual Property
- By virtue of the MDE’s role in product development and patent support functions, they are constantly exposed
to confidential information and trade secrets. In this capacity the MDE is expected to assure complete
confidentiality of such information with the scope of their authority. - The MDE fosters a creative work environment, inspiring and encouraging coworkers to contribute ideas freely
and openly for consideration.
Regulatory, Quality, & Safety - Assures design compliance with applicable statutory requirements, medical regulatory requirements, and
associated safety standards. - Assumes a lead role in product safety during the design and development of all Exsurco products.
- Assumes a major role in assuring that all product designs meet the full expectation of Exsurco quality
requirements. - Assumes overall responsibility for ensuring that engineering-related documentation meets current standards and
practices. - Assumes a lead role in the creation and maintenance of internal product development/support procedures and
standards. - Conducts engineering activities within the limits of approved programs and broadly defined policies, directives,
and procedures.
SKILLS/QUALIFICATIONS:
- BS in Mechanical Engineering or equivalent from an accredited educational institution and 7+ years direct work
experience in medical product design, including 5+ years of leading product development efforts executed by
multi-disciplinary teams. OR - MS in Mechanical Engineering from an accredited educational institution and 5+ years direct work experience
in medical product design, including 5+ years of project management executed by multi-disciplinary teams.
KNOWLEDGE, SKILLS, AND ABILITIES
- Solid project management and leadership skills.
- Excellent communication (oral, written, and listening) and interpersonal skills.
- Team oriented; Able to interact with all levels of employees; Good facilitation skills.
- Proficient in Microsoft Office (Word, Excel, & PowerPoint).
- Proficient in Microsoft Project or equivalent project management software.
- Proficient in the use of Computer Aided Design, preferably SolidWorks.
- Proficient in the use of Computer Aided FEA, preferably SolidWorks Simulation.
- Proficient in the use of PDM software, preferably Oracle PLM.
- Highly experienced with all aspects of product risk management.
- Expert with the comprehension and application of medical device regulations, consumer product regulations,
and associated safety standards to product design and testing. - Must be able to learn, understand, and apply new technologies.
- Expert at conducting research into product-related issues
PERSONAL CHARACTERISTICS:
- Behave Ethically: Understand ethical behavior and business practices and ensure that own behavior and the behavior of
others is consistent with these standards and aligns with the values of the organization. - Communicate Effectively: Speak, listen and write in a clear, thorough and timely manner using appropriate and effective
communication tools and techniques. - Creativity/Innovation: Develop new and unique ways to improve function efficiency and performance.
- Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve problems, and make decisions
that enhance process effectiveness. - Organize: Set priorities, develop a work schedule, monitor progress towards goals, and track
details/data/information/activities. - Plan: Set goals, create and implement actions plans, and evaluate the process and results.
- Solve Problems: Assess problem situations to identify causes, gather and process relevant information, generate possible
solutions, and make recommendations to manager. - Exsurco Values: Aligns to and demonstrates Empowerment, Unity and Commitment.