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<h3>Job Description</h3>
Badger Talent Solutions is partnering with one of its top clients seeking a Manufacturing Engineer to join the team at their Milwaukee, WI facility. This full-time, on-site position is a key link between product development and production, offering the opportunity to drive innovation, improve processes, and support the successful launch of new medical device products in a regulated environment.
 
This role is ideal for an engineer who thrives on cross-functional collaboration, project ownership, and continuous improvement.
 
Key Responsibilities:
<ul>
<li>Partner with New Product Development teams to optimize design for manufacturability and scalability</li>
<li>Define and implement process requirements for new product launches</li>
<li>Create and execute IQ/OQ/PQ validation protocols for equipment, tooling, and processes</li>
<li>Lead initiatives around scrap reduction, lean manufacturing, and value engineering</li>
<li>Evaluate and improve production layouts and process flows</li>
<li>Utilize project management tools to track milestones and report progress</li>
<li>Drive process improvements through automation and best practices</li>
</ul>
 
Qualifications:
<ul>
<li>Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or Biomedical preferred)</li>
<li>5+ years of experience in a manufacturing environment </li>
<li>Proficient in process validation, lean manufacturing, and root cause analysis</li>
<li>Six Sigma certification preferred (Green or Black Belt)</li>
<li>Experience with AutoCAD and SolidWorks preferred</li>
<li>Excellent project management, problem-solving, and communication skills</li>
</ul>
 
Our client is known for its innovative products, collaborative culture, and commitment to quality. If you're ready to take the next step in your engineering career, where your contributions truly shape product and process success, we’d love to connect with you.

Process Engineer

<h3>Job Description</h3>
Job description
 
We are an early-stage med tech company based in Newark and seeking an experienced, dynamic and collaborative principal engineer to join its team. This candidate will lead the company's R&amp;D activities to launch new product development and existing product improvement initiatives. The Principal Engineer will be responsible for the development of specifications and leading design activities. This is a managerial as well as technical engineering role that requires investigation of new processes and application of advanced engineering methodologies. The Principal Engineer will work in a cross-functional team environment and will oversee and mentor junior engineers.
 
Responsibilities of the Principal Engineer Candidate:
 
• Lead the R&amp;D team to develop new products and existing product improvement initiatives for multiple clinical applications in parallel
• Be able to effectively and efficiently manage contract manufacturing partners and vendors.
• Identify and analyze design problems to achieve optimal solutions that satisfy technical requirements
• Formulates new, innovative approaches (IP) to solve technical problems
• Leads product specifications, risk documents and conducts technical and design reviews
• Ensures that project deliverables meet Company, FDA and ISO requirements
• Supports, prepares, and participates during internal and external audits
• Deal with FDA directly, be able to work easily with regulatory consultants and professionals, as well as be very familiar with quality procedures and compliance with ISO13485 standards and 510K applications
• Build and implement capability in project planning, resource management, and integrated project reporting; able to hit milestones effectively
• Develop and deliver clinical training programs using effective communication and presentation skills; clinical trials management and training of nurses and physicians on devices from the Company
• Lead decision analysis with the team in R&amp;D
• Identify and negotiate functional resources to assemble an appropriate cross-functional project team within budget
• Provide technical knowledge and project management expertise to project programs (in various functional areas as necessary) to ensure proper focus and advancement.
• Communicate effectively with management, quality and regulatory professionals, and others regarding the status of all activities and align them to project deliverables.
• Inform management in a timely manner of any problems, which may result in a delay in project schedules. Identify means to minimize impact to the project timeline and budget.
 
Requirements:
 
• BS in Mechanical or Biomedical Engineering, Masters and/or PhD preferred; Electrical Engineering/CS and/or Optics knowledge and experience preferred
• 6-12+ years of product development experience in the medical device industry
• Experience in optics and optical engineering, microbiological test protocols and microbiology, electrical engineering, and plastic injection molding is a plus; being able to communicate with the right technical specialists listed above is a must.
• Demonstrated ability to solve complex design and engineering problems
• Experience building experimental test set-ups to characterize and assess functional performance of medical products
• Experience in patent writing and in formulating and interacting with patent counsel, design of technical protocol testing and in leading design, development, verification and validation processes in medical device development process is a must
• Excellent communication skills needed
 
Key relationships include and not limited to: Quality, Regulatory, Engineering, Marketing, Manufacturing, Procurement, Clinical Specialists, Hospitals, and External Vendors.

Principal Engineer

<h3>Job Description</h3>
DEPARTMENT:&nbsp;Engineering
REPORTS TO:&nbsp;Director of Operations&nbsp;
OVERTIME STATUS:&nbsp;Exempt
SALARY RANGE:&nbsp;$80,000 - $120,000
 
ABOUT US:
Pacific Lasertec is a leader in the design and manufacture of high-quality Helium-Neon lasers, serving a diverse range of customers within the semiconductor, biomedical, scientific, and metrology industries. Founded in 2019, we strive to build on the success of the legacy Melles-Griot HeNe product line to meet the growing need for high performance, low-cost laser systems. Our highly vertically integrated business brings design, fabrication, assembly, and test in-house to guarantee strict control over all processes. We are seeking talented and motivated personnel to join our experienced team and become an integral part of the next generation of laser manufacturing experts.
 
 
SUMMARY:&nbsp;
The Manufacturing Engineer is responsible for ensuring the efficient production of high-quality laser systems. They will lead continuous improvement initiatives, optimize manufacturing processes, develop tooling, perform failure analysis, and provide technical expertise for the operations and R&amp;D teams. Working closely with a cross-functional group, they will support new product introductions and coordinate their release to ensure smooth transitions to production. This role will drive operational excellence by leveraging technical expertise and strategic thinking to streamline workflows, improve reliability, and ensure on-time, cost-effective production.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
 
•\tLead efforts to develop, evaluate, improve, and document manufacturing methods.
•\tInterpret engineering drawings and specifications to create effective work instructions.
•\tAssess manufacturing capabilities, resource requirements, technical and logistical constraints, and work with operations and management to meet production goals.
•\tDevelop and implement cost reduction and yield-maximization projects.
•\tDesign and coordinate the manufacture or purchase of test fixtures and equipment.
•\tConfer with vendors to determine product specifications and arrange the purchase of equipment, materials, and parts to facilitate production.
•\tAnalyze field and process failures, disposition material, and implement design or process changes to address root cause.
•\tCollaborate with development teams to ensure manufacturability of new products, design necessary tooling, and coordinate their release to production.
•\tPerform Design and Process Failure Mode Effect Analysis.
•\tMaintain BOM and routing information
•\tTrain personnel in manufacturing procedures.
 
EDUCATION and EXPERIENCE:
•\tB.S. in mechanical, electrical, or manufacturing engineering or related field and four years relevant experience&nbsp;
 
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
REQUIRED SKILLS:
•\tFour years of hands-on experience as a manufacturing engineer or equivalent position in an optics, photonics, electronics, precision machine, or similar manufacturing environment
•\tProficient with CAD (e.g. SolidWorks)
•\tAbility to effectively apply GD&amp;T to drawings
•\tFamiliarity with precision machining and additive manufacturing methods
•\tExperience in manufacturing execution and product data management systems (MES/PDM)
•\tProven track record using modern manufacturing techniques to meet production objectives
•\tAbility to gather, interpret, and perform statistical analysis on technical data
•\tAttention to detail and commitment to quality
•\tStrong communication and interpersonal skills
•\tProficient with Microsoft Office
 
DESIRED SKILLS:
•\tExperience developing, testing, or analyzing lasers, optics, photonics, or optical instruments
•\tDemonstrated experience designing and implementing automated test stations
•\tFamiliarity with electronic lab equipment such as oscilloscopes, multimeters, power supplies, spectrum analyzers, and soldering stations
•\tWorking knowledge of Lean Manufacturing methods
•\tSix-sigma green belt certification
 
LANGUAGE:
•\tMust read, analyze, and interpret professional journals, technical procedures, or governmental regulations in the English language.&nbsp;
•\tWill sometimes write reports, business correspondence, and procedure manuals.&nbsp;
•\tMust effectively present information and respond to questions from groups of managers, other employees, and customers.
 
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•\tResponsible for transporting items and material up to 25lbs occasionally.&nbsp;
•\tMust visually inspect materials to identify nonconformances in shape, finish, and color
 
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•\tStandard office and manufacturing environment with moderate noise.
•\tPosition may involve working with and/or exposure to high voltage and/or laser beams.

Manufacturing Engineer

<h3>Job Description</h3>
Company:
For over 50 years, Hitemco has been partnering with leading edge technology companies to help make critical surfaces successful. We specialize in high performance surface coatings and understand the thin line between a critical part and the environment that it operates in. Whether it’s in aerospace, energy, minerals, or transport, we work with our customers to deliver outstanding materials knowledge, fast production turn times, reliable forecasts, and great customer service.
Lincotek Group is a world leader in the coatings industry and is active, through its different operating business units, in the European, Asian and American continents, with four main divisions: Aerospace, Industrial Gas Turbine, Biomedical, and Equipment. 
Position Summary
The Quality Engineer must possess experience in a Special Process Industry with increasing responsibilities in Quality, Engineering or Operations. Strong focus on quality systems (e.g. AS9100, NADCAP), process qualifications, nonconformance management, continuous improvement. 
 
Essential Functions
<ol>
<li>Report all metrics for Safety, Quality, Delivery, and Cost for the organization are met and trending in the right direction.Proper production preparation, quality, time accuracy, through the implementation of continuous improvement are key.</li>
<li>Prepare for and manage all source inspections if required as well as working with the customer and internal organization.</li>
<li>Read, analyze, and discuss customer required specifications managing all qualification kick-off meetings and put decisions into actions. </li>
<li>Read, analyze, review and update internal procedures as necessary. </li>
<li>Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercise judgment within generally defined practices and policies to determine appropriate action and to solve a variety of problems. Analyze nonconforming reports, returned products and recommends corrective action.</li>
<li>Develop, revise, apply and maintain quality procedures, quality plans, documents and work instructions in accordance with IS09001, AS9100, NADCAP, S1000, industry standards, and customer requirements. Participate in product development to assure all quality issues are addressed.</li>
<li>Implement requirements related to AS13100 (i.e. PFMEA, Control Plans, Gage R&amp;R, Process Flow Diagrams).</li>
<li>Implement methods of procedures for inspecting, testing, and evaluating the precision and accuracy of products and calibration of equipment. Performs a variety of duties to independently perform dimensional, visual and non-destructive testing of diversified components and assemblies to ensure fabrication and equipment are in compliance with engineering, industry standards and customer approved documents.</li>
<li>Interface with all areas of the company, its customers and suppliers on quality issues. Initiate and maintain the implementation and closure of corrective actions. Participate in the resolution of corrective actions and verifications of actions implemented.</li>
<li>Review shop Travelers and identify quality related requirements to purchase orders.</li>
<li>As required, perform internal &amp; external audits and surveys with compliance to the Management Systems, industry standards, and customer requirements. Develop reports based on inspection and audit results. Participate in audits from external sources.</li>
<li>Participate in Root Cause Corrective Action activities to permanently eliminate defects. Utilize 8D and 5 Why approach to problem solving and non-conformances.</li>
<li>Adhere to the Company's Quality and Safety Management System and in accordance with its procedures and requirements. </li>
<li>Utilize Lean and Six Sigma methods to improve Key Performance Indicators for Safety, Quality, Delivery, and Cost.</li>
<li>Perform all duties in accordance with all company policies including adherence to good safety practices. Training of personnel.</li>
<li>Performs other duties as assigned.</li>
</ol>
 
Supervisory Responsibility
 
None
 
Position Type/Expected Hours of Work
This is a Full -time position, Monday through Friday 8am to 4:30, with additional hours as business needs necessitate.
Travel
Occasional overseas and domestic travel may be required to support the rapid growth of the company.
 
 
Education and Experience 
 
<ol>
<li>A Materials Science, Mechanical or Chemical Engineer bachelor’s degree or over 5 years equivalent Quality Assurance experience is required.</li>
<li>ISO9001, AS9100, NADCAP experience required. </li>
<li>GE S1000, Six Sigma and Lean Manufacturing experience preferred.</li>
<li>AS9100 Internal Auditor Certification required.</li>
</ol>
 
 
 
Hitemco LLC. A Lincotek Group Company provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Quality Engineer

<h3>Job Description</h3>
DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.
RECRUITERS: DO NOT CONTACT.
 
Role Description
Perform the research, development and testing of lasers, laser systems, and fiber optic delivery devices for surgical applications. Provide knowledge of photonics and lasers, particularly high-power pulsed, Q-switched, and diode driven fiber optic lasers. Build bench-level prototypes and conduct experiments to lead understanding of system and single-use device design requirements. Work closely with other members of our small, interdisciplinary team developing innovative laser devices and related technologies in a focused, fast-paced and fun environment. Provide progress reports on program performance and ensure deadlines are met. This position will require you to translate raw ideas into high-level design concepts and prototypes.
 
Roles and Responsibilities:
<ul>
<li>Evaluate performance and maintain a high standard for performance within the Laser &amp; Optics team.</li>
<li>Assemble, align, test, and troubleshoot surgical lasers, laser delivery systems, and single-use devices.</li>
<li>Build and align laser and fiber optic prototypes, taking them from bench-level to functional designs.</li>
<li>Couple high-energy, free space lasers to photonic components and fiber optic devices.</li>
<li>Conduct lab experiments, collect and analyze resulting data, document and present results.</li>
<li>Work with manufacturers to define requirements for components and subsystems and realize prototypes.</li>
<li>Derive product design requirements based on top-level requirements and user needs input.</li>
<li>Medical device development activities such as prototyping and testing, pilot builds, V&amp;V, risk assessment, and validation of ramp-up to production.</li>
<li>Contribute to patent portfolio and strategy development. </li>
</ul>
 
Education
<ul>
<li>Master’s Degree or equivalent in Optical Engineering, Physics, Electrical Engineering or similar disciplines with five or more years of relevant experience.</li>
</ul>
 
Required Experience
<ul>
<li>Area knowledge in Photonics, Fiber Optics, Lasers and Laser Systems.</li>
<li>Experience working with high-energy, Q-switched, diode driven fiber optic, or other solid-state lasers and related electronic, optical and optoelectronic equipment required.</li>
<li>Development of lasers, laser systems, fiber optic energy delivery devices, fiber optic probes, is an advantage.</li>
<li>Proficiency with industry standard tools and methods for laser, photonic, and electro-optical systems engineering. </li>
<li>Broad knowledge of assembly, alignment, powering, and test methodologies and related equipment.</li>
<li>Hands-on experience in laboratory technical work, preferably in lasers, photonics and optics.</li>
<li>Experience in documenting technical work and results, writing lab reports, analysis and presentation of data.</li>
</ul>
 
Knowledge, Skills, and Abilities
<ul>
<li>Biomedical product or medical device development experience. </li>
<li>Experience with Class 3B &amp; Class 4 lasers and related optics for delivery and single-use devices.</li>
<li>Solid understanding of Design Controls according to 21 CFR 820 or ISO 13485. </li>
<li>Proficient in Risk Management according to ISO 14971.</li>
</ul>

Photonics Engineer

<h3>Job Description</h3>
Job Title: Process Engineer
Location: Seattle-Dexter, WA
Schedule: Normal Business Hours
Hybrid: (50%+ days onsite required, days of week are flexible)
Job ID: 62721
Per manager, the Top 3 – 5 Must Have's a candidate should have are:
Top Skills Required:
<ul>
<li>Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations. Looking for a proactive and independent thinker.</li>
<li>Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.</li>
<li>Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.</li>
<li>Exceptional interpersonal and communication skills, with a demonstrated ability to build strong relationships and a positive reputation with various teams and stakeholders.</li>
</ul>
 
Top Skills:
<ul>
<li>Life Cycle Management Experience</li>
<li>Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.</li>
<li>Familiarity with cell therapy processes and cGMPs</li>
<li>Experience assimilating large data sets in support of batch history sections for regulatory submissions.</li>
<li>Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.</li>
</ul>
 
Position Summary
Cell Therapy Technical Operations (CTTO) is responsible for global product lifecycle strategy and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle. The Senior Engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life-cycle management of a commercial CAR-T Therapy. This includes establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level. This role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of challenges/opportunities. The candidate will help drive the validation, qualification, and comparability strategies.
 
Duties/Responsibilities
<ul>
<li>Lead the commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.</li>
<li>Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.</li>
<li>Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.</li>
<li>Provide technical content for significant documents such as validation activities, author content for regulatory submissions.</li>
<li>Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.</li>
<li>Provide necessary technical analysis to support impact assessments and investigations.</li>
<li>Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.</li>
<li>Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.</li>
<li>Present complex technical topics internally and externally.</li>
<li>Share operational and process leanings with the rest of the manufacturing network.</li>
</ul>
 
Qualifications
<ul>
<li>Bachelor's or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. Familiarity with cell therapy processes and cGMPs is preferred.</li>
<li>Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.</li>
<li>Experience working in a self-driven, performance/results oriented, fast paced matrix environment.</li>
<li>Experience assimilating large data sets in support of batch history sections for regulatory submissions. Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.</li>
<li>Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.</li>
<li>Ability to assess risk and develop contingency plans for process risks</li>
<li>Able to manage time and elevate relevant issues to project lead and line management.</li>
<li>Detail oriented with excellent verbal and written communication skills.</li>
<li>Strong interpersonal and leadership skills to work with teams in different functions and organizations.</li>
</ul>

<h3>Job Description</h3>
COMPANY DESCRIPTION
Nanova Biomaterials, Inc. (NBI), established in 2013, is committed to our mission “to continuously improve our products beyond the industry standards through rigorous research and development.” Particularly, NBI’s dental division with its focused but all-inclusive R&amp;D provides high-quality dental devices and consumables to consumers and is committed to meet our customers’ needs and demands beyond the industry standards. Currently, NBI’s operation takes place in our facilities in Columbia, Missouri.
OVERVIEW
Under general supervision, the Manufacturing Engineer will be responsible for engineering activity in dental product operation area, functioning as project lead on manufacturing capital improvement project as assigned, and driving continuous improvement through lean manufacturing principles. This position will interface directly with all levels of manufacturing and will be accountable for the principal job functions listed below.
DUTIES AND RESPONSIBILITIES
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Serve as the project lead of a cross-functional team to identify and implement continuous improvement opportunities of dental product lines or processes. This can include:
Ø&nbsp;Process mapping, time studies or other lean manufacturing techniques to identify efficient and effective improvements
Ø&nbsp;Ingredient or supplier consolidations to reduce material costs without negatively impacting product quality
Ø&nbsp;More effective orders of operation to increase capacity or improve product quality
Ø&nbsp;Material changes to support higher production efficacy
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Manage the critical manufacturing processing or packaging schedule to maximize output while minimizing costs including active participation in problem solving to achieve these results.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Provide guidance for technicians and/or hourly employees on assigned tasks and projects. Coordinate schedules and work required by associates to complete projects in a timely manner.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Work with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Ensuring regulatory compliance through Validation &amp; Verification. Responsible for determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Work closely with R&amp;D and Marketing team to support new product development and new product introduction (NPI). 
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Responsible for providing related manufacturing documentation including production requirements and specifications, Bill of Materials (BOMs), work instructions and process document control, etc. 
PREFERRED QUALIFICATIONS
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Education:&nbsp;B.S. in Chemical, Mechanical, Industrial, Materials Science, or Biomedical Engineering. 
·&nbsp;&nbsp; Experience: 0-3 years of relevant manufacturing experience or equivalent combination of education and experience.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Skills:&nbsp;Good verbal and written communication skills. Great planning, analytical and problem-solving skills. 
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Abilities:&nbsp;Ability to work in groups, learn quickly and be a leader to complete work, Ability to manage multiple projects. 
PHYSICAL REQUIREMENTS
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Able to sit, stand, stoop, bend, and walk frequently during the shift. May be necessary to work extended hours as needed and on weekends.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;May need to lift up to 40 lbs. on occasion.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Ability to travel 10% or less. Visit trade shows, vendors or customers to provide technical assistance when needed.
COMPENSATION AND BENEFITS
Competitive compensation package including paid vacation plan; medical, dental and vision plan; 401(k) plan with matching company contribution.

<h3>Job Description</h3>
CFD Research Corporation is seeking a Mechanical Engineer to join our team and play a pivotal role in the design, development and integration of complex systems for our customers. This position is a new role that will work on a growing team of engineers and technicians and will encompass conceptual design, prototyping, and testing in support technology development programs designed and prototyped at our new Hollywood, Alabama Engineering Test Center, located a short distance from our Headquarters in Huntsville, AL. To learn more about the Hollywood Engineering Test Center capabilities and state-of-the-art equipment, please visit the facility's home page: <a href="https://www.cfd-research.com/hollywood/" target="_blank">https://www.cfd-research.com/hollywood/</a>
 
The ideal candidate will have experience working engineering tasks related to concept development, design, fabrication, and prototyping hardware. One challenge for this opening will be to help facilitate functionality between the engineering team and production/prototyping facility. Previous experience in an AS9100 environment is preferred. The candidate should be comfortable interacting with multiple stakeholders, including the government customer. This position will require a driven individual with a common-sense approach to hardware engineering and a passion for building/making/testing technologies.
 
Basic Qualifications:
<ul>
<li>Candidate must be a US Citizen and meet eligibility to obtain (and maintain) a Secret Clearance</li>
<li>Position requires a Bachelor's Degree in Mechanical or Aerospace Engineering (or similar STEM discipline) and at least 5 years of relevant experience</li>
<li>Experience designing and developing prototype hardware</li>
<li>SolidWorks or other CAD experience</li>
<li>Designing for manufacturing methods including milling and turning operations</li>
</ul>
 
Desired Qualifications:
<ul>
<li>Familiarity with AS9100 process</li>
<li>Generation of Technical Data Packages (TDP)</li>
<li>Interpreting results from CFD and FEA analysis tools to inform design</li>
<li>Experience with aerospace hardware</li>
<li>Experience with CNC machinery</li>
</ul>
 
Location: This individual will work onsite in Hollywood, AL.
 
About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace &amp; Defense, Biomedical &amp; Life Sciences, Intelligence &amp; Sensing, and Energy &amp; Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for four of the last five years. Learn more at <a href="http://www.cfd-research.com" target="_blank">www.cfd-research.com</a>
 
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers a highly competitive insurance package, including medical, vision, and dental insurance. We offer company paid leave, compensation time, parental leave, long-term and short-term disability, accidental death and dismemberment, and life insurance. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.
 
CFD Research is an EO employer - Veterans/Disabled and other protected categories

Mechanical Engineer

<h3>Job Description</h3>
Job Summary
The Manufacturing Engineer is responsible for leading advanced manufacturing processes, driving process improvements, and ensuring the highest quality standards in the production of orthopedic implants and instruments. This role provides technical expertise, strategic leadership, and hands-on support for process development, automation, and validation while collaborating with cross-functional teams to optimize manufacturing operations.
 
Responsibilities
Manufacturing Process Development &amp; Optimization:
<ul>
<li>Design, develop, and implement cutting-edge manufacturing processes for orthopedic implants and surgical instruments.</li>
<li>Lead process validation (IQ, OQ, PQ), ensuring compliance with FDA, ISO 13485, and GMP regulations.</li>
<li>Identify and implement automation, robotics, and advanced machining solutions to enhance efficiency.</li>
<li>Optimize CNC machining, and additive manufacturing processes for cost-effective and high-quality manufacturing/production.</li>
<li>Develop work instructions, standard operating procedures (SOPs), and process flow documentation to support manufacturing/production.</li>
</ul>
Continuous Improvement &amp; Lean Manufacturing:
<ul>
<li>Drive Lean Six Sigma, Kaizen, and 5S initiatives to enhance productivity, reduce waste, and improve process reliability.</li>
<li>Lead root cause analysis and Corrective/Preventive Action (CAPA) implementation to resolve manufacturing issues.</li>
<li>Develop and execute strategies to reduce cycle times, scrap rates, and production costs while maintaining quality standards.</li>
</ul>
Equipment, Tooling, &amp; Technology Advancement:
<ul>
<li>Oversee selection, installation, and validation of state-of-the-art manufacturing equipment and tooling.</li>
<li>Work closely with R&amp;D and product development teams to ensure design for manufacturability (DFM) and design for assembly (DFA).</li>
<li>Collaborate with suppliers and vendors to identify new materials, coatings, and machining technologies for orthopedic applications.</li>
</ul>
Regulatory Compliance &amp; Quality Assurance:
<ul>
<li>Ensure all manufacturing processes comply with FDA, ISO 13485, and GMP standards.</li>
<li>Partner with Quality and Regulatory teams to support audits, inspections, and process documentation.</li>
<li>Utilize statistical process control (SPC) and data-driven decision-making to maintain product integrity.</li>
</ul>
Leadership &amp; Mentorship:
<ul>
<li>Provide technical leadership and mentorship to junior engineers and manufacturing teams.</li>
<li>Serve as a subject matter expert (SME) in manufacturing engineering, troubleshooting complex production challenges.</li>
<li>Collaborate with cross-functional teams, including R&amp;D, Quality, and Supply Chain, to drive innovation and efficiency.</li>
</ul>
 
Requirements
<ul>
<li>Education: Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field </li>
<li>Experience: Minimum of 3 (??) years in manufacturing engineering, preferably in the orthopedic or medical device industry.</li>
<li>Technical Skills:</li>
<li>Expertise in CNC machining, additive manufacturing (3D printing), and precision assembly.</li>
<li>Proficiency in CAD/CAM software (SolidWorks, Mastercam, SmartCam, or similar).</li>
<li>Strong background in process validation, statistical analysis, and DOE (Design of Experiments).</li>
<li>Experience with automation, and robotics</li>
<li>Certifications (Preferred): Lean Six Sigma Black Belt, PMP, or equivalent industry certifications.</li>
<li>Soft Skills: Strong analytical skills, leadership, problem-solving, and effective communication abilities.</li>
</ul>
 
About Onkos
At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.
At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.
 
At Onkos Surgical, we will:
<ul>
<li>Find solutions to our patients’ unmet clinical needs and advocate for their cause.</li>
<li>Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.</li>
<li>Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.</li>
<li>Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.</li>
<li>Deliver value to our customers and shareholders.</li>
</ul>

<h3>Job Description</h3>
About Us:
Our Client is a leading innovator in the medical device industry, committed to improving patient outcomes through cutting-edge technology and high-quality products.
 
Job Summary:
We are seeking a motivated and detail-oriented Entry-Level Medical Device Associate to join our growing team. This role is designed for recent graduates or professionals early in their careers who are passionate about healthcare technology and eager to grow within the medical device industry. You’ll receive hands-on training and mentorship in a dynamic, fast-paced environment.
 
 
Key Responsibilities:
<ul>
<li>Support cross-functional teams with documentation, testing, reporting, and compliance tasks</li>
</ul>
 
<ul>
<li>Assist in the preparation and maintenance of technical documents and regulatory submissions</li>
</ul>
 
<ul>
<li>Perform product inspections, testing, and validation under supervision</li>
</ul>
 
<ul>
<li>Help manage data entry, inventory, and records in support of production or quality operations</li>
</ul>
 
<ul>
<li>Collaborate with engineers, sales reps, and quality professionals on product support and problem-solving</li>
</ul>
 
<ul>
<li>Ensure adherence to company policies and industry regulations (FDA, ISO, etc.)</li>
</ul>
 
<ul>
<li>Participate in internal audits and continuous improvement initiatives</li>
</ul>
 
<ul>
<li>Maintain a clean, safe, and organized work environment</li>
</ul>
 
 
 
Qualifications:
<ul>
<li>Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Mechanical Engineering, Healthcare, Business, etc.)</li>
</ul>
 
<ul>
<li>Strong organizational skills and attention to detail</li>
</ul>
 
<ul>
<li>Ability to learn quickly and work collaboratively in a team-oriented environment</li>
</ul>
 
<ul>
<li>Excellent written and verbal communication skills</li>
</ul>
 
<ul>
<li>Proficiency in Microsoft Office (Excel, Word, PowerPoint)</li>
</ul>
 
<ul>
<li>Interest in medical technology and commitment to patient safety</li>
</ul>
 
<ul>
<li>Internship or co-op experience in healthcare, biotech, or manufacturing is a plus</li>
</ul>

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