Sr. Biomedical Engineer – Product Development

Sr. Biomedical Engineer – Product Development

Impressio, Inc. is a platform material solutions provider to major global manufacturers, and an emerging leader in new Product Development for various surgical orthopedic applications. We are actively searching for an experienced Senior Engineer in medical device Product Development to join our R&D team. This engineerwill be responsible for fulllife cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance.Excellent communication and interpersonal skills, five plus years of medical device design and development experience and a bachelor’s degree in engineering, or a related field, are essential for this position. Experience in CAD software is required, and experience with biologic devices and project management experience are strongly preferred. This position will be located at our Denver, CO. Join our talented team to Materially Transform the Most Important Products in the World.

Essential Duties and Responsibilities:

· Design components and modify existing designs to develop or improve products and facilitate manufacturing operations

· Implement test protocols to assess the mechanical properties, biocompatibility, and durability of materials and medical device products

· Participate in the development of new medical devices and processes using collagen scaffolds/composites, providing insight and recommendations based on test results and analysis

· Determine budgets and timelines for assigned projects

· Lead multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget

· Analyze test data and prepare comprehensive reports to summarize findings, conclusions, and recommendation

· Maintain accurate documentation of design history, test procedures, results, and observations, adhering to regulatory requirements and quality standards

· Manage FDA Material Master File, Pre-submission, and 510(k) submission as required

· Provide Regulatory technical support for assigned projects as needed

· Stay up-to-date with medical device regulations and apply relevant knowledge to optimize testing methodologies and improve product performance

· Support Marketing and Product Management with technical information to be used for training and marketing of assigned products.

· Report progress and status of assigned projects on a timely basis

Education & Experience

· 5 years of relevant experience

· BS, MS, or PhD in Biomedical engineering, or a related field, with an emphasis in medical device prototyping, testing (verification and validation), and FDA clearance

Skills:

· Knowledgeable of FDA and ISO guidelines for the development of medical devices required

· Technical knowledge in development methodologies, design, and project implementation

· Experience with medical device clearance as well as validation & verification testing

· Ability to interpret and analyze test data, and effectively communicate findings to both technical and non-technical stakeholders

· Excellent problem-solving skills and attention to detail

· Strong organizational and time management abilities, with the ability to manage multiple projects simultaneously

· Ability to lead a technical team with a defined budget and timeline

· Manufacturing process knowledge preferred

· Project management and strong communication skills preferred

· Working knowledge of anatomy from an orthopedic standpoint preferred

· Working knowledge of joint anatomy preferred

· Proficiency in designing products using a 3D-CAD program

· Knowledge of orthopedic surgery principles, theories, and products preferred

· Historical perspective on orthopedic surgery principals, theories, and products preferred

· Excellent written and oral communication skills

Compensation

Impressio will carefully consider a wide range of compensation factors, including your background and experience. Full-time Impressio employees are eligible for medical, dental, and vision insurance, as well as a matching 401(k) retirement plan, stock options, paid time off.

Base Pay: $80,000 - $90,000 plus bonus.

Location

Requires applicant to work onsite in Denver, Colorado.

Offices located at 7270 Gilpin Way, Ste 120, Denver CO, 80229, USA

Please submit your cover letter and resume to: INFO@IMPRESSIO.TECH

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Stock options
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Denver, CO 80229: Relocate before starting work (Required)

Work Location: In person