$48 per hour
Responsible for coordination and management of system design for one or more groups of related products (i.e. ?Programs?) to achieve defined program goals.
This includes work related to the development of new products, and maintenance and engineeringsupport of existing products.
Interfaces with other departments including Marketing, Sales, Service, Operations, Quality Assurance and Regulatory Affairs to define product requirements, communicate important information, and address issues relative to each product.
Position Responsibilities:?Work withEngineering Project Management to define and scope projects to achieve program goals.
Participate as a member of project teams for the assigned program.
Work with Upstream Marketing to understand and translate market needs into technical product requirements.
As a leader of the technical team, ensure technical product requirements are communicated and understood by the technical staff.
Owner of the Design History File (DHF). Responsible for ensuring technical product requirements are clearly and thoroughly documented.
This includes the following:
- Creation of system level specifications. o Ensures usability requirements are adequately addressed per IEC 62366.
- Lead technical resource for Risk Management per IEC 14971. o Coordination and review of design level requirements to ensure they meet the system requirements and market needs.
- Coordination and review of system and design level requirements to ensure they adequately consider serviceability and manufacturability of the product.
- Responsible for DHF traceability by ensuring all requirements have been verified and validated.
- This includes creation of Verification and Validation Plans to scope the extent of testing required to maintain adequate traceability is maintained during a development project. This also includes completion of all documentation required to ensure compliance to standards.
- Ensures requirements shared by similar products and their implementations are harmonized across those products, where possible.
- Work with technical writing to ensure user documentation is sufficient.
- Ensure end product configurations (MIS-14s, etc.) are created and updated as necessary to meet the market needs.
- Leader of the Program Support Team. Specific duties are as follows:
- Manages periodic Program Support Team meetings.
- Primary point of contact for Technical Support escalations. o Assist with complaint investigations as needed.
- Participate in CAPA activities as needed. o Management of Post Market Record investigations.
- Resource for Post Market risk assessments. o Management of Field Action Determinations.
- Assists with explaining project information or processes in a regulatory or supplier audit.
- Performs other duties as requested. Essential competencies:
- Bachelor?s Degree in Engineering or related field and/or equivalent experience and 2+ years of experience.
- Must have strong organizational skills. ? Must be fluent in English (both oral and written) with excellent oral and written communication skills.
- Works independently, is self-motivated and able to complete tasks with minimal supervision. ? Must have the ability to initiate and develop creative solutions.
- Acts with a sense of urgency, illustrates ambition and drives for completion of tasks/projects. ? Strong proficiency in Office applications skills.
- Must be a team player, possess outstanding customer service skills and be self-motivated. ? Possess good listening skills, and easily learn new skills and concepts.
- Ability to manage time and prioritize work. ? Must be flexible and adaptable. ? Possess the ability to manage time and prioritize critical priorities.
- Must demonstrate the ability to increase knowledge.
Physical demands and work environment:
Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone. Work environment: The work setting is an office environment which has minimal noise level.
Proficient in Microsoft Office applications
Familiarity with product Risk Management Familiarity with design and manufacture of devices in a regulated industry (e.g. medical, aerospace, pharmaceutical, energy, automotive, etc.).
Experience with ISO13485, 14971, 62366, 60601-1.
Experience with IBM Rationale DOORS and/or SAP.
Experience in medical device industry.