Senior Design Engineer

CQ Medical•New Garden Township, PA

About The Position

Responsible for design and technical development in new product development, with a focus on innovative products. The role works with Manufacturing and Project Management to support smooth production startup and provides technical design or process engineering support for existing products and continuation engineering initiatives. It provides advanced technical leadership within the engineering group. The Senior Design Engineer designs and develops products primarily outside existing product lines; leads R&D investigations into new materials and design or manufacturing techniques; generates product-development and quality-system documentation; and provides technical input and decision-making on product design. The role works with project engineers to understand and meet schedules, communicates regularly with Manufacturing and Project Management, and interacts with OEMs and customers on technical matters as needed. It also develops project and product cost estimates. The role follows engineering and company processes, including ISO 9001 processes, and is expected to keep current with relevant technology, attend training, participate in clinical evaluations, and pursue further training and education. It mentors junior mechanical designers, entry-level engineers, interns, and other engineering staff; advises staff on CAD capabilities and issues; and may represent Engineering on technical matters in various capacities.

Requirements

Bachelor's degree in engineering from a four-year college or university, and at least eight years of related experience and/or training, or an equivalent combination of education and experience.
Expert knowledge of CAD systems, advanced analysis tools, and/or manufacturing processes.
In-depth understanding of intellectual property and patent concepts, and ability to communicate these concepts with engineering staff.
Experience following ISO 9001 processes.
Experience with Microsoft Excel, Microsoft Word, and Microsoft Project.
Experience with manufacturing processes including injection molding, machining, and assembly.
Demonstrated interpersonal, organizational, and time-management skills.
Ability to perform the essential duties satisfactorily, with reasonable accommodations available for individuals with disabilities.

Nice To Haves

Experience with ISO 13485, ISO 14971, FDA, and MHLW requirements.
Related product and equipment knowledge.

Responsibilities

Designs and develops products primarily outside existing product lines.
Leads R&D investigations into new materials and design or manufacturing techniques.
Generates product-development documentation as needed.
Provides input and makes decisions on technical matters related to product design.
Works with project engineers to develop and understand project schedules and work within them.
Communicates regularly with Manufacturing and Project Management throughout projects.
Communicates with OEMs and customers on technical matters as needed.
Develops cost estimates for projects and products.
Generates quality-system and project-related documentation as needed, including DHF documents, work orders, and charters.
Understands and follows engineering-related and overall company processes, including ISO 9001 processes.
Attends relevant training, keeps abreast of technology developments, participates in clinical evaluations, and pursues further training and education.
Mentors junior mechanical designers and entry-level engineers on CAD.
Provides technical guidance and support to junior engineers and interns.
Advises staff on CAD-related problems and capabilities.
Provides technical leadership and mentoring within Engineering.
Represents Engineering in various capacities, such as CO and MRB, on technical issues as required.
Applies design, documentation, materials management, design-for-manufacturing, process management, design software management, and troubleshooting/problem-solving skills.