Development Engineer I

Creative Solutions Services, LLC; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Development Engineer I for a 1 year contract in Warsaw, IN, onsite only. The role focuses on new product design, development, and commercialization of orthopedic devices, with strong emphasis on regulatory alignment and risk management.

You will work under supervision and with senior peers to translate user needs into design inputs, develop production specifications, and participate in verification and validation activities for market-ready products.

Qualifications

• ABet-accredited bachelor of science in engineering (or global equivalent) inMechanical, Biomedical, or related fields.
• Understanding of product design processes and regulatory standards.

Responsibilities

• Stays current with arthroplasty product use, clinical procedures, regulations and standards.
• Identifies user needs via engagement with surgeons and observation of device usage.
• Translates user needs into design inputs to meet market needs and regulatory requirements.
• Creates product designs and documents rationale for design features.
• Prepares invention disclosures and patent-related information.
• Coordinates prototype production, verification, validation and process validation with cross-functional teams.
• Creates production specs accounting for manufacturability and inspection.
• Documents critical-to-quality features and generates inspection plans.
• Evaluates designs to reduce user risk and complies with regulatory requirements.
• Authorizes design control and risk management documents for development.
• Supports design transfers for production of market release quantities.

Education

ABET-accredited BS in engineering

Job description

Development Engineer I
1 Year Contract
Warsaw, IN (100% Onsite)

Duties

You have a key support role with responsibility for new product design, development, and commercialization; and/or to maintain in the market innovative medical device products in order to further our client's mission and grow our client's market leadership position.

Principal Duties and Responsibilities:

With oversight from supervisor and mentorship by senior peers:

• Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards

• Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage

• Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards

• Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features

• Prepares and reviews information for invention disclosures and patents

• Initiates, provides instruction for and coordinates with support from Client cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation

• Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection

• Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated

• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Client procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)

• Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Client procedures and global regulatory requirements

• Supports Client Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Skills

You have a key support role with responsibility for new product design, development, and commercialization; and/or to maintain in the market innovative medical device products in order to further our client's mission and grow our client's market leadership position.

Principal Duties and Responsibilities:

With oversight from supervisor and mentorship by senior peers:

• Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards

• Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage

• Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards

• Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features

• Prepares and reviews information for invention disclosures and patents

• Initiates, provides instruction for and coordinates with support from Client cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation

• Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection

• Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated

• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Client procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)

• Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Client procedures and global regulatory requirements

• Supports Client Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Education

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.#TechAM