Sr Engineer- Disposables R&D at Vontive

Plymouth, Minnesota, United States

Vontive Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare, Kidney CareIndustries

Requirements

  • Bachelor degree in mechanical, plastics, Biomedical Engineering, or a related field; Master Degree preferred
  • 3+ years of related experience in Class II or Class III disposables medical product development
  • Design for Six Sigma (DFSS) training or certification preferred
  • Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
  • Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks)
  • Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems
  • Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices

Responsibilities

  • Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes and product development (e.g. new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation)
  • Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools (e.g. dFMEA, Human Factors Engineering, statistical software, CAD)
  • Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings
  • Develop and execute test method validations, product testing, and verification / validation activities
  • Build prototypes and models; may operate machine tools, design and build basic tooling, test fixtures and assembly equipment
  • Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance
  • Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices

Skills

Key technologies and capabilities for this role

CADdFMEAHuman Factors EngineeringTest Method ValidationProduct VerificationProduct ValidationDesign History FileStatistical SoftwarePrototypingMachine ToolsTooling DesignMedical Device Design

Questions & Answers

Common questions about this position

What is the salary range for this Sr Engineer position?

This information is not specified in the job description.

Is this role remote or does it require office work?

Vantive supports flexibility in the workplace through a flexible workplace policy.

What skills and experience are required for this role?

Candidates need a Bachelor's degree in mechanical, plastics, Biomedical Engineering or related field (Master's preferred), 3+ years in Class II or III disposables medical product development, knowledge of plastics processing, CAD/PDM software, FDA Design Controls, ISO 13485, and ISO 14971. DFSS training or certification is preferred.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who don't settle for mediocre and are driven to improve patients' lives worldwide.

What makes a strong candidate for this Sr Engineer role?

Strong candidates will have a relevant engineering degree with 3+ years in medical disposables development, expertise in plastics processing and CAD, and knowledge of FDA/ISO regulations, plus DFSS certification.

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters
2017Year Founded
$32.1MTotal Funding
DEBTCompany Stage
Financial Services, Real EstateIndustries
11-50Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Unlimited Paid Time Off
Parental Leave
Short- and Long-term Disability Coverage
Life Insurance
Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.
Potential regulatory scrutiny may lead to higher compliance costs and challenges.
Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.
The platform integrates financial institutions through a unique debt marketplace.
Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.
The company has financed over $1.1 billion in residential properties since April 2022.
Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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