Senior Project Engineer

We are seeking a Senior Project Engineer for a very important client.

JOB SUMMARY: Works with and across the various disciplines of the engineering team, operations, quality, regulatory, and business development for project realization.

One of the primary functions of the position is to be the technical leader, control DHF documentation and be the project manager to drive development projects.

This will be achieved by establishing proper design specifications, project plans, and other DHF documentation to meet customer requirements.

JOB DUTIES:  Responsible for product development projects to support growth of the business.

 Accountable for achieving quality objectives, creating/meeting development schedules and project budgets, as well as communicating program status and escalating issues when appropriate to facilitate transparency.

 Leading cross-functional program activities for timely completion of projects within budget  Managing and optimizing project plans, product/project risk, project budgets, and resources/task assignments  Working closely with cross functional team members to effectively facilitate decision making to deliver effective and timely new product development products  Ensuring compliance to design control procedures, Design History File (DHF) and other QMS requirements  Managing customer objectives, regulatory requirements, schedules, and program risks  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  Contribute to documentation needed for the Design History File and Technical File.

 Ensure project team activities and decisions are clearly communicated, documented and archived.

 Maintain working knowledge of the system design and performance against the requirements  Clearly communicate with manageme The ideal candidate will possess the following qualifications: Able to look ahead and plan while anticipating and prepping activities for execution in an effective and efficient method.

 Ability to create a schedule while collaborating cross functionally to ensure accuracy  Experience in the medical device industry and exposure to medical device development over multiple projects/life cycles is required.

 Experience with working in ISO 13485 and 21 CFR Part 820 compliant environments  Proven experience with Design Control Process and management of sub-teams or significant Project efforts.

 Skilled in leading multi-disciplinary teams including Engineering, Regulatory, Quality, Purchasing, Planning, and Production, in an FDA regulated environment.

 Able to communicate clearly and concisely to provide information, direction, and or guidance.

 Self-starter with an ability to multi-task.

ACCOUNTABILITY:  Assume responsibility and ownership 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.

Job Requirements: 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.

LANGUAGE SKILLS: 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.

SUPERVISION RECEIVED: 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.

SUPERVISION EXERCISED: No direct subordinates.

Supervision of an engineering intern may be assigned.

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.

ADVERSE WORKING CONDITIONS The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

There are no adverse working conditions outside of a general plant environment.