What are the responsibilities and job description for the Sr Product Development Engineer - Catheters position at Resolution Medical?

Job Type

Full-time

Description

Job Summary

Activities include product design and development, defining technical solutions to abstract problems, defining methods and processes, design modeling, tooling design / fabrication, equipment design / fabrication, personnel management, design verification and validation, and documentation. Manage the day-to-day execution of reliability tasks by teams and team members through monitoring progress, providing technical direction, and problem-solving solutions. Design and develop innovative products, incorporating Design for Manufacturability and Assembly principles, managing the product design from concept to full production.

This position will lead in the execution of development projects as part of a multi-functional project team.

We anticipate hiring this role in March of 2025 to support upcoming projects.

Essential Functions

Research, design and implement new products based on customer specifications
Develop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and / or standards)
Understand the end use of products, determine fitness-for-use of materials, and effectively advancing the specification development of new and derivative products
Specify and develop tests for product testing determining acceptability of designs to requirements
Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis
Develop tooling and test equipment designs for product assembly and testing
Prepare and present plans and schedules as Technical Project Lead
Serve as Technical leader, and cross-functional team member representing Product Development, for development projects (as assigned). Duties include : task management, organize and facilitate technical team meetings, lead technical reviews, provide documentation and coordinate project activities
Perform as a technical resource to all departments with a thorough understanding of related disciplines
Contribute to the development of project plans that meet the required customer and / or internal milestones, specifications, and product cost goals, within project budget and staff assignments
Communicate progress and decisions to customers, associates and functional managers
Assist management in improving systems for product development, standard operating procedures, safety, quality control and training
Identify opportunities for productivity and quality improvements
Perform product / process analysis for cost reduction, quality improvement, and improved efficiency
Perform research, design and development of product assembly methods including production equipment
Create breakthrough strategies that alter the competitive dynamics in a market and establishes a series of competitive advantages yielding profitability that exceeds expectations for the organization
Perform formal root cause analysis
Provide risk based decision making using formal risk management tools
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
Follow company policies and procedures

Requirements

Functional Knowledge

Good engineering techniques

Knowledge of human anatomy

Able to effectively communicate about very technical subjects with peers and customers

Knowledge of machining and assembly practices, tools and fixturing is required. Knowledge of plastic and / or metal is preferred

Education, Experience, Required Skills

Bachelor's degree in related field (equivalent work experience may be considered)

Catheter shaft design and development experience, preferably in the cardiovascular market required

5 years of medical device industry experience as an individual contributor, with at least 4

years in catheter shaft design and development.

Strong strategic focus in the areas of Product and Process Development is ideal but not required

Ability to handle and be trusted with confidential and / or sensitive information

Strong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner

Must have knowledge of machining and assembly practices, tools and fixturing (plastic and / or metal preferred)

Experience in contract design or manufacturing (preferred but not required)

Proficiency in 3D CAD Software (preferably SolidWorks) In addition to fixture design, must be able to open, view and manipulate assemblies

Demonstrated ability to implement change, in a way that positively impacts overall department and company performance

Must be able to handle multiple projects simultaneously

Must excel at working in a team environment with a high level of people / interpersonal skills and demonstrated ability to cross functionally drive results

Excellent written and verbal communication skills, emotional regulation? Is there a way to talk about this as a soft skill?

Able to work in a fast-paced, constantly changing environment

Ability to be flexible and to handle multiple projects in an organized, timely manner

Able to problem-solve, work under pressure, and to effectively manage stress

Ability to work overtime if needed

Ability to occasionally travel to support projects and customer requirements

Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer

Must be able to lift up to 25 pounds at times

Must wear gown, gloves, ear protection and other personal protective equipment when applicable

Summary of Benefits

Group health & welfare benefits : Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.

Company-paid benefits : Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).

Voluntary, employee-paid benefits : Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.

Flexible Time Off Program

Paid Parental Leave

Paid Holidays

Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

The typical base pay range for this role is between $105,000-135,000 / year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.

401(k) Plan : Company-provided Safe Harbor Contribution of 3% of eligible earnings.

Salary : $105,000 - $135,000

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