Lead Mechanical Engineer

Sun Scientific, Inc.; Village of Dobbs Ferry (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Sun Scientific, Inc. in Dobbs Ferry, NY is seeking a Lead Mechanical Engineer for wearable medical devices to drive hardware development across concept, design, prototyping, and manufacturing transfer.

You will work with PMs, ID, and Quality to ensure design robust through V&V, DFM, and cost targets, and you will mentor junior engineers while owning critical documentation and risk management. This is a hands-on leadership role in a fast-growing medical device company with opportunities to shape

Qualifications

• 5+ years' experience designing and launching hardware products in a structured process with cross functional teams.
• Has worked on Engineering Teams for several successful new product launches through all development phases, either owning a whole product or sufficiently complex subsystem.
• Able to manage project timelines and execute deliverables to that timeline.
• Proven ability to work with and understand the functions of a cross functional product development team and assign/manage contributions of junior MEs.
• Has personally performed design analysis and design decisions for products and components. Responsible for concept, prototyping and DFM/MFG and quality requirements.
• Has a deep experience-based understanding of the purpose and activities of each development phase and ability to explain and guide teams within this structure.
• Experience with estimating timing and resource requirements for a variety of product development projects in collaboration with cross functional teams.
• Proven track record of working with Product Managers and Industrial Designers to define products and find innovative design solutions to challenging problems.
• High level of proficiency with at least 1 CAD system.
• Ability to choose appropriate prototyping methods for each phase of development. Experience with 3D printing, casting, fabric prototyping, etc.
• Testing: write detailed test plans and requirements for design validation and work with testing labs to execute.
• Quality: design control documents for medical device development. DIOVV, DFMEA, DHF, etc.
• Manufacturing Transfer: designing manufacturing methods and managing vendor communication through DFM. Injection Molding, die-cutting, ultrasonic welding, stitching.
• RCA/Problem Solving: Root Cause Analysis techniques and application.
• Med Device: experience with medical devices, Class 1 & 2 preferred
• Language: Fluent written and spoken English

Responsibilities

• In this role you will be a core member of the new product development team together with Product Managers, Industrial Designers, and Product Development Quality Engineers.
• In early development phases you will contribute to product concept ideas, perform feasibility assessments, and study new technologies and materials. You will be responsible for translating product requirements to testable and quantifiable Engineering Requirements.
• You will partner closely with industrial designers and soft-good designers to create detailed product definitions through design and prototyping (CAD, materials, assemblies, etc.) and ensure all product technical, manufacturability and cost requirements are met.
• You will collaborate with PD Quality Engineers to perform risk management activities and to plan and execute all Validation and Verification requirements.
• In this role you are the primary stakeholder of functional testing to validate device performance and reliability and responsible for guiding design iteration after testing.
• You will be the primary contact with supplier technical teams, responsible for DFM and ensuring correct MFG processes and product cost targets.

Skills

Hardware design

Product launches

Cross-functional teamwork

Project management

CAD

Prototyping

Testing

Design for Manufacturing

Medical devices

Tools

CAD software

3D printing

Validation & Verification

MFG processes

Injection molding

Job description

LEAD MECHANICAL ENGINEER (Wearable Medical Devices)

Sun Scientific | R & D Division

Department: R&D

Location: Dobbs Ferry, NY.

Type: Full-Time

Position Summary:

We are looking for an exceptionally talented LEAD MECHANICAL ENGINEER to join our R&D and Engineering team. Sun Scientific is a fast-growing, patient-centric medical device company bringing wearable therapeutic products into the future — with applications in both healthcare and consumer wellness. This is a hands-on, high-impact role where you will push the form, fit, and function of our current and in-development product lines using the latest in material science, manufacturing processes, and design thinking.

Key Responsibilities

• In this role you will be a core member of the new product development team together with Product Managers, Industrial Designers, and Product Development Quality Engineers.
• In early development phases you will contribute to product concept ideas, perform feasibility assessments, and study new technologies and materials. You will be responsible for translating product requirements to testable and quantifiable Engineering Requirements.
• You will partner closely with industrial designers and soft-good designers to create detailed product definitions through design and prototyping (CAD, materials, assemblies, etc.) and ensure all product technical, manufacturability and cost requirements are met.
• You will collaborate with PD Quality Engineers to perform risk management activities and to plan and execute all Validation and Verification requirements.
• In this role you are the primary stakeholder of functional testing to validate device performance and reliability and responsible for guiding design iteration after testing.
• You will be the primary contact with supplier technical teams, responsible for DFM and ensuring correct MFG processes and product cost targets.

Required Qualifications

Experience:

• 5 + years' experience designing and launching hardware products in a structured process with cross functional teams
• Has worked on Engineering Teams for several successful new product launches through all development phases, either owning a whole product or sufficiently complex subsystem.
• Able to manage project timelines and execute deliverables to that timeline.
• Proven ability to work with and understand the functions of a cross functional product development team and assign/manage contributions of junior MEs.

Design Ownership

• Has personally performed design analysis and design decisions for products and components. Responsible for concept, prototyping and DFM/MFG and quality requirements.

Product Development Process

Has a deep experience-based understanding of the purpose and activities of each development phase and ability to explain and guide teams within this structure.

Project planning/scoping

Experience with estimating timing and resource requirements for a variety of product development projects in collaboration with cross functional teams.

Cross Functional Team Member

Proven track record of working with Product Managers and Industrial Designers to define products and find innovative design solutions to challenging problems.

CAD Experience

High level of proficiency with at least 1 CAD system.

Prototyping

Ability to choose appropriate prototyping methods for each phase of development. Experience with 3D printing, casting, fabric prototyping, etc.

Testing

Ability to write detailed test plans and requirements for design validation and work with testing labs to execute.

Quality

Experience with design control documents for medical device development. DIOVV, DFMEA, DHF, etc.

Manufacturing Transfer

Strong experience designing specific manufacturing methods and managing vendor communication through DFM. Knowledge of Injection Molding, die-cutting, ultrasonic welding, stitching.

RCA/Problem Solving

Experience with Root Cause Analysis techniques and ability to apply techniques to functional and manufacturing problems.

Med Device

Significant portion of experience from work developing medical devices, Class 1 & 2 preferred

Language

Fluent written and spoken English

Preferred

Soft Goods

What Success Looks Like in the First Year

You have completed engineering design, quality, testing, and MFG transfer work for development projects that are currently in-flight. You have worked with ID and PM teams to establish clear and repeatable development process phases. You have contributed technical knowledge about materials, components, and MFG technology to help scope future roadmap products.

Core Competencies

Product design, development and testing Cross-functional team planning and communication Leadership and mentorship for junior engineers FDA regulated medical device design and quality Manufacturing transfer and supplier communication

Why Join Sun Scientific

This is a rare opportunity to join an innovative product development team inside a fast-growing, clinically respected medical device company. You will have a direct line to leadership, real influence over product design, and the chance to shape the engineering team and culture.