Staff Development Engineer (CNC Swiss), Lead

Resonetics•Blaine, MN

19h•$120,000 - $140,000

About The Position

Overview Resonetics, the world leader in micro manufacturing for the life sciences industry, is changing the industry and elevating the customer experience resulting in rapid growth domestically and internationally. This is a phenomenal opportunity to join an innovative, fast-paced organization with an employee focused culture and put their mark on something meaningful. This individual will be responsible for scaling up small volume to medium volume projects and developing a manufacturable process during this scale up. If current technologies are not in house, this individual would work with management to identify this and source. This individual will have swiss technicians report directly to them and would be responsible for the work of the group. They would be responsible for creating programs using Esprit and or Solidcam and planning and ordering all materials and tooling necessary and creating all inspection and job documentation for small batch runs done in the lab. They would also coordinate with other engineers in the lab to plan equipment, and assist in transitioning Lightspeed projects to production through the defined NPI process in a small team and collaborative environment.

Requirements

Bachelor’s degree in engineering/science or equivalent, with 8+ years of experience (6+ years with a Master’s).Prior experience and/or training in production setting and comparable manufacturing preferred.
4+ years of Citizen Swiss set up or similar
4+ years of programming experience using Esprit and or SolidCam
7+ years experience in medical device product design and development.
Experience leading small groups
Proven understanding of tooling requirements to setup and operate CNC Swiss machines, including pre-setting of tools.
Ability to create job related documentation for quality purposes
Ability to read and edit programs.
Ability to read and understand engineering drawings per GD&T system
Ability to generate drawings and models with 2D & 3D software using GD&T (Solidworks).
Ability to read and understand blueprints and specifications.
Strong math background, preferable in machine math/shop math.
Ability to apply software used on high precision manufacturing equipment (G-code).
Strong communication and organizational skills
Strong project management experience leading cross-functional teams in a technical environment.
Strong analytical and data-driven approach with proven problem-solving abilities.
Strong presentation, written, and verbal skills.
Ability to communicate with all levels within the organization.
Solid team leadership, team building, and facilitation skills.
Demonstrated mediation skills and ability to resolve apparently conflicting requirements through effective communication.
Ability to facilitate a collaborative working environment for customers and team members.
Comfort communicating and/or presenting in front of clients and large project teams.
Ability and willingness to travel.
Close familiarity with FDA QSR and ISO 13485 medical device regulations.
Experience in all phases of the medical device product development lifecycle.
For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.

Nice To Haves

Familiarity with ISO Quality System, particularly in medical device manufacturing.
Basic understanding of materials science and materials properties, especially for common medical device materials (Nitinol, Stainless Steels, Titanium & other metals, Medical Polymers and Ceramics)
Ability to create and troubleshoot programs for inspection devices and other auxiliary equipment
Technical degree in Mechanical or Biomedical Engineering.
Depth of knowledge in one or more clinical areas.
SolidWorks proficiency.
Knowledge of probability and statistics.
Experience with transfer to production and/or sustained manufacturing of complex medical devices.

Responsibilities

Program new parts and improve existing parts using Esprit or Solidcam software
Oversee R&D (Lightspeed) job ensuring consistent quality is achieved, participate in advanced process development on Resonetics technology
Plan Swiss jobs: this includes ordering raw materials, tooling and creating inspection docs per print requirements. Also creating the program and training the technicians on whats required by the customer.
Work to Quote/Cost new project request by customers in a timely manner.
Leads customer meetings.
Communicates directly with clients in a timely and professional manner.
Participates in calls with prospective clients as a subject matter expert.
Mentor, train and oversee the work done by swiss technicians
Work with customers on new projects: this includes up front communication discussions on DFM, timelines and feasibility. You would also be responsible for customer updates on active projects.
Set-up and operate CNC Swiss machines as needed. (Citizen L12 and L20)
Executes on broadly defined technical challenges/high level requests, defining specific direction for themselves and team members to achieve the desired outcome.
Displays creative problem-solving skills.
Provides technical oversight to junior engineers and guides troubleshooting efforts.
Demonstrates deep technical expertise in specific technical and/or clinical areas.
Demonstrates superior productivity, independence, attention to detail, and self-motivation.
Works unsupervised, exercising independent judgment within primary job functions.
Demonstrates an understanding of all technologies and facilities across Resonetics.
Is able to identify and explain opportunities for vertical integration to junior engineers and to clients.
Maintains a growth mindset by actively seeking and accepting constructive feedback.
Help with equipment setup utilizing loosely defined setup process and advanced troubleshooting of Resonetics technology workstations
Document process parameters and project details for each Lightspeed project accurately per Resonetics Quality Systems requirements
Good understanding of how to develop processes and working with technical writers to create work instructions as needed.
Update data in Resonetics digital systems for responsibilities as instructed with feedback from Engineering
Utilize applicable inspection equipment to perform tight tolerance visual and hand tool inspection of Lightspeed product for complex parts
Read and interpret print specifications on Lightspeed projects, ensure all required visual, GD&T and geometric measurements are taken and documented per Quality Systems requirements
Ability to work under minimal supervision, taking responsibility to complete assigned tasks
Must ensure assigned tasks are completed within the defined timeline while ensuring safety and quality are never sacrificed
Seeks continuous self-improvement, open and willing to accept constructive criticism
Provide project guidance and technical skill training for Technicians
Demonstrating and training manufacturing methods to Production operators to support new Resonetics programs
Ability to adapt quickly and positively to changing priorities and processes
Employee must conduct themselves in a professional and appropriate manner and is responsible for maintaining a high standard of conduct and job performance.
Actively participate in continuous improvement activities
Demonstrates an ability to adapt quickly and positively to changing priorities and processes.
Demonstrates an understanding of the common inspection techniques used in medical device design and manufacturing.
Incorporates Design for Metrology principles into their work.
Demonstrates an understanding of manufacturing priorities (efficiency, yield, line balancing).
Routinely incorporates DFM and DFA principles when completing design tasks.
Enforces an NPI mindset in interactions with junior colleagues.
Demonstrates familiarity and compliance with Quality SOPs.
Has experience in all Product Development Process (PDP) phases sufficient to lead a project from Phase 0 through Phase 5.
Demonstrates strong time management and organizational skills.
Employs organizational tools to optimize personal performance.
Demonstrates functional application of advanced Solidworks skills.
Is able to coach junior engineers through complex modeling tasks.
Drafts complex drawings with a demonstrated understanding of component manufacturing methods.
Is proficient in GD&T.
Is able to successfully contribute to multiple projects concurrently.
Assists junior team members with prioritization and time management.
Works with a clear sense of urgency and prioritizes a diverse workload.
Other duties as assigned