Manager, Applications/Systems engineer

Job Summary:
The Supervisor of Applications Engineering is responsible for developing processes and organizational structure to deliver on expanded product portfolio offerings, both through internal development as well as via external partnerships, that meet or exceed established quality, reliability, delivery and cost targets and to facilitate strategic growth of the business. This position will direct and implement a comprehensive product management strategy through design, modification, and evaluation of all phases of product design.

Duties and Responsibilities

• Conceive, maintain, and execute schedule by monitoring progress, coordinating activities, and resolving problems. Implement, manage, and communicate program changes and oversee the tracking and execution of program deliverables
• Lead design and change control activity, including but not limited to requirements, risk analysis, verification, and validation protocols and reports, design transfer.
• Implement metrics as required bringing visibility to product and program health. Reports project status and key issues to senior management on a regular basis.
• Lead process improvement as required to deliver the scope of work assigned.
• Facilitate design reviews according to quality requirements, ensure appropriate technical authorities are represented and design feedback is incorporated.
• Collaborate with Sales to help define customer requirements, run clinical testing of prototypes, effectively react to key issues/changes to requirements
• Responsible for the development of requirements and the execution of resource allocation, plans and schedules. Recommend cancellation of projects that will not meet objectives.
• Partner with other functional groups to define the product content/feature set and system requirements. Resolve differences within and between teams.
• Responsible for ensuring appropriate level of product testing and documentation throughout all phases of development.
• Attend trade shows, conference and customer visits.
• Maintain superior knowledge of competitive technologies in addition to relevant medical, technical and biomedical developments.
• Work with Quality to support the establishment and maintenance of site-specific quality systems.
• Analyze staffing requirements, production times, and costs to provide data for operational decisions.

Required Knowledge, Skills and Abilities

• Solid working knowledge of standard computer applications including MS Word, Excel, Outlook and PowerPoint. Intermediate to advance in statistical, project management, solid modeling, failure analysis and scheduling software.
• Communicate clearly and professionally with internal and external customers.
• Work effectively as part of a team to achieve established outcomes. Understand other's roles and empower one another to take responsibility to be successful. Demonstrate a collaborative interaction with peers to reach a common goal.
• Pay close attention to detail in all aspects of the job
• Make decisions using available resources and sound judgment
• Maintain confidentiality and discretion
• Identify and resolve problems in a timely manner, gather and analyze information skillfully
• Effectively teach, coach, and counsel associates by effectively communicating and providing follow-up.
• Open to other's ideas and exhibits a willingness to try new things.
• Demonstrate accuracy and thoroughness; monitor work to ensure quality.
• Prioritize and plan work activities to use time efficiently.
• Adapt to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.
• Follow instructions, responds to direction, and solicits feedback to improve.
• Act in such a way to instill trust from management, other associates, as well as customers.
• Familiar with standard concepts, practices, and procedures within an ISO13485 facility

Education and Experience

• Bachelor level degree in Mechanical Engineering or equivalent degree in natural or physical sciences
• 8 years of experience, preferably in a medical device or other FDA regulated industry using a Quality System. Strong grasp of GMP standards and requirements for FDA, EU, IEC/UL.
• Experience interfacing with suppliers to support process development and cost reduction for new products a plus

Preferred Experience

• Advanced degree in Engineering or business
• Six Sigma, Lean Manufacturing or similar certification
• Experience working with FDA and ISO 13485 for product development

Physical Demands:

The physical demands described here are representative of those necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable individuals with disabilities to perform the essential functions.

• Constant: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboard; frequently move about the office
• Constant: Specific vision abilities required by this job include close vision requirements due to computer work for full shift
• Seldom: Lift and/or move up to 20 pounds
• Seldom: Ability to uphold the stress of traveling
• Constant: Regular, predictable attendance is required
• Constant: While performing the duties of this job, the employee is regularly sitting for the full shift.
• Seldom: This position requires balance, bend/stoop, climb stairs, crawl, crouch, kneel; Constant: keyboard/type, push, pull, reach, reach above shoulder, repetitive motion as well as computer/mouse use.

Frequent: Ability to wear personal protective equipment that may include some or all: safety glasses, lab coat, safety shoes, gloves, hearing protection, hair/beard covering. No make-up or nail polish permitted.