Sr Mechanical Design Engineer - Exempt

Must Have:
3D CAD/ Design Engineer
• Ability to use statistical techniques to analyze data
Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
develop injection molding
Production Part Approval Process Training

Nice to Have:
Authored Performance Qualification Protocol
Created Installation Qualification and Operational qualification

JOB DESCRIPTION
In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality. You will be responsible for reviewing supplier documentation including First Article Inspection Reports and OQ/PQ documentation and assisting with new component supplier qualifications with help from the Released Product Engineering team.
Top 3 technical skills that are required for the role:
3D CAD/Design Experience
Advanced Understanding of GD&T
Production Part Approval Process Training
Education Required: Bachelor’s Degree in Mechanical Engineering or Similar Engineering Degree
Years’ Experience Required: Minimum of 4 years of relevant experience
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours per week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, 3 days on site minimum
What is your timeline for scheduling interviews? Interviews in June
What product line will this person support? LigaSureTM and SonicisionTM products under Advanced Surgical Technologies

Sr. Mechanical Design Engineer
Careers that Change Lives
Help streamline and speed our time to market and build quality in at every step. You will be a member of the Released Product Engineering team that supports the design, development, and maintenance of innovative, new medical device products, as well as commercially released products within the Advanced Surgical Technologies business. You can apply advanced technical concepts to complex problems throughout the product life cycle.
In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality. You will be responsible for reviewing supplier documentation including First Article Inspection Reports and OQ/PQ documentation ensuring parts meet specification and applying statistical techniques as neccessary. Assisting with CAD and print updates for new component supplier qualifications with help from the Released Product Engineering team.
A Day in the Life
Ensures that suppliers deliver quality parts, materials, and services.
Qualifies suppliers according to company standards
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Generates 3D models and prints with a strong undertanding of GD&T fundementals
Evaluates FAI, OQ, and PQ data associated with a product par approval process and applies statistical techniques as necessary.
Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy and Control Plans for new components.
Must Haves:
Bachelor’s degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
Product Part Approval Process Experience
Understanding of IQ, OQ, PQ
Molding Experience
Understanding of GD&T
3D CAD and modeling experience
Experience using statistical techniques like process capability
Nice to Have
Degree in Engineering or Scientific discipline
Detail-oriented with strong commitment to quality and to the workplace.
Excellent analytical, organizational, and communication skills. Strong ability to work with multidisciplinary and global teams.
High tolerance for change, and ability to multi-task continuously.
Strong negotiation, conflict management, and influence management skills.
Experience in the medical device industry.
About ***
Together, we can change healthcare worldwide. At ***, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.