Report on Senior Project Design Engineer - 7+ Medical Device Exp. At Confidential Company
Senior Project Design Engineer - 7+ Medical Device Exp. At Confidential Company
Works with and across the various disciplines of the engineering team, machine shop personnel, operations, quality, regulatory, and business development for project realization with a focus on design for manufacturability, inspection, and assembly of product. Areas of focus will be the design and development of products, technical lead, project manager, and be responsible for the control of DHF documentation to drive development projects. This will be achieved by establishing proper design specifications, project plans, and other DHF documentation to meet customer requirements.
- Responsible for product development projects to support growth of the business.
- Provides technical support to Management, Business Development, Engineering, Manufacturing, QA/RA, and Purchasing as needed or when requested.
- Leads cross-functional program activities managing customer objectives, regulatory requirements, schedules, program risks, as well as clearly communicating program status and escalating issues when appropriate to facilitate transparency.
- Accountable for achieving quality objectives, creating/meeting development schedules and project budgets, managing and optimizing project plans, product/project risk, and resources/task assignments.
- Participation as group facilitator and/or creator of documentation of requirements, inputs, outputs, specifications, and test protocols/reports in support of Verification and Validation activities.
- Ensuring project team activities and decisions are clearly communicated, documented, and archived.
- Ensuring compliance to design control procedures, Design History File (DHF) and other QMS requirements
- Contribute to documentation needed for the Design History File and Technical File.
- Creates and develops designs from customer requirements to proof of concept to fully actualized and commercialized products.
- Evaluates and troubleshoots problems, issues, or challenges in the design that may affect performance, manufacturing, inspection, and assembly processes to provide solutions.
- Must be able to perform and demonstrate all developed and existing manufacturing, inspection, and assembly processes in a general hands-on approach.
- Gathers information for analysis to provide data on existing as well as proposed manufacturing, inspection, and assembly processes for good decision making. This may include calculating production costs through labor, methods/processes, time, equipment, and materials.
- Works and collaborates with outside suppliers in acquiring information for new development requirements or in working through problems, issues, and/or challenges.
- Complies with regulations and established company policies, procedures, and processes to ensure best practices are followed that ensure all products or processes meet specifications and/or requirements.
- Performs other duties as assigned.
SKILLS AND QUALIFICATIONS:
- A Bachelor’s Degree of Science in Mechanical Engineering or related field is required. Advanced Degree is a plus.
- A minimum of 7 years of related industry experience is required.
- 3+ years project management in a cross-functional environment.
- Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x.
- Experience with design controls for medical devices Title 21 CFR 820 and ISO 13485 is preferred.
- Experience with Risk Management ISO 14971 is preferred.
- Proficient with Project Management tools including Microsoft Project to create project schedules, determine critical path, and account for all activities to complete a task/deliverable with the appropriate resources accounted for while utilizing good work breakdown structure.
- Ability to create a schedule while collaborating cross functionally to ensure accuracy.
- Proven experience with Design Control Process and management of sub-teams or significant project efforts over multiple projects/life cycles is required.
- Skilled in leading multi-disciplinary teams including Engineering, Regulatory, Quality, Purchasing, Planning, and Production, in an FDA regulated environment.
- Experience with 3D Solid Modeling CAD software is required – Solidworks preferred.
- Hands-on experience with the design and development of small electromechanical systems/devices is preferred.
- Experience with Design For Manufacturability/Inspection/Assembly (DFMIA).
- Good understanding of ASME Y14.5 Geometric Dimensioning & Tolerancing (GD&T) and how it relates to the design, manufacturing, inspection, and assembly processes or procedures.
- Able to conduct tolerance stack-up analysis is required.
- Able to apply statistical methods to analyze data for testing, manufacturing, inspection, and assembly processes. Able to gather information and data quickly and efficiently for analysis to provide direction and guidance for good decision making.
- Assume responsibility and ownership of assigned tasks with minimal direction and guidance.
- Exercise initiative and judgement with data driven decision making.
- Provide support to team members, customers, and others in the company as required.
- Assure all regulations, policies, procedures, or processes are followed as specified by the company.
- Utilize standards and best practices where appropriate.
- Maintain a safe working environment.
- Hands on approach to problem solving.
- Expected from time to time to put in extra time and effort to complete critical tasks to meet deadlines or objectives for the company.
INTERPERSONAL AND COMMUNICATIONS SKILLS:
- Team Environment: Must be able to work in a fast paced team environment and collaborate in a positive and professional manner. This may include taking on tasks and responsibilities overlapping with other team members.
- Conflict: Must be able to negotiate and resolve issues with team members and management in a positive and professional manner.
- Communication: Must be a strong communicator able to convey clear and concise information to team members, management, or customers. Good listening skills are required.
- Ownership: Must be able to take ownership of problems, issues, or challenges with minimal guidance to troubleshoot and work through them.
Must possess the ability to read, write, speak, and comprehend the English language. Must be able to read, analyze, and interpret documents such as safety rules, operating and maintenance procedures.
Receives direction and guidance based on determined work objectives and priorities mandated by the company and/or its officers or supervisors. Participates and collaborates in the approach to assignments based on objectives and priorities. Plans, organizes, schedules, and arranges activities based on objectives and priorities with minimal supervision.
No direct subordinates.
MENTAL, PHYSICAL, AND VISUAL DEMANDS:
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak type and move throughout the facility and must be capable of using a keyboard for computer purposes. This role may require the employee to stand for long periods of time while setting up and monitoring equipment. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds. The employee may be required to conduct inspections under magnification.
Ability to utilize a computer, telephone, fax and copy machine are required as well as other general office equipment. In addition, general shop, inspection tools, and CNC machinery may be required from time to time.