Engineering and Management Consultant for the medical device industry with over 28 years of experience in both start-up and established companies. I help clients accelerate product development by quickly identifying and plugging gaps in their development execution or strategy. What sets me apart from other consultants is that I enjoy getting hands-on to not only advise, but “to do”. This includes any element of product development, from early-stage concept testing through post-launch optimization. With over 50 product launches under my belt, my background allows me to rapidly deliver high quality deliverables with very little training and oversight.
Email Steven Robertson at togethersolvers@gmail.com
Service offering examples:
Research and Development (R&D):
- Specification development
- Concept / feasibility studies
- Design verification, design validation
- Human Factors
- Biocompatibility and Preclinical studies
- DHF and filing documentation / compliance to standards
- Due diligence
Project Management:
- Direct Project / Program Management
- Broken / delayed projects
- Project kick-off and planning
- Project schedule optimization
- Establishing a PMO
- PMO best practices, culture, and metrics
Operations:
- Process development and validation
- IQ / OQ / PQ
- GR&R
- Contract manufacturing oversight and contract review
Quality and Regulatory:
- Risk Management (DFMEA, PFMEA, URRA, Risk Benefit)
- FDA PMA and Breakthrough products
- Maneuvering through complex quality and global regulatory requirements
- Crisis management
Executive Leadership:
- R&D, Project Management Office, Operations
- Start-up support
- Interim support
- Flexible to a variety of financial arrangements and partnerships
Technologies include:
Neurovascular, Cardiovascular, Peripheral Vascular, Active Implantable, Stents, Coils, Intrasaccular Devices, Catheters, Guidewires, Balloons, Liquid Embolics, DBS, IPG and Leads, Wound healing, Oncology, Ophthalmic
Company Details
- Founded
- -
- Address
- Orange County, California, Us
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Keywords
- Engineering Consulting, Management Consulting, Executive Consulting, Medical Device Consulting, Research and Development, R&D, Project Management, Program Management, Product Development, Operations, Quality, Quality Engineering, Project Planning, Project Acceleration, Neurovascular, Endovascular, Active Implantable, PMA, PMO, DHF.
- HQ
- Orange County, California
Together Solvers Llc Questions
Together Solvers Llc's LinkedIn profile is https://www.linkedin.com/company/together-solvers-llc
Together Solvers Llc's industry is
Medical Equipment Manufacturing
Together Solvers Llc's top competitors are
Neucore Bio,
Trivirum,
Enumera Molecular,
Neuros Medical, Inc.,
Vs3 Medical,
Wells Pharmacy Network,
Landi Industries,
Warwick Communications,
Jenavalve Technology, Inc.,
Cirtec Medical.
Together Solvers Llc's categories are Medical Equipment Manufacturing
Together Solvers Llc's founding year is 2022
